Therapeutic evaluation of treatment with EDTA-NS irrigation solution for open fracture wound: A Prospective, Double-Blind, Randomized, Multicenter clinical Trial

Start Date01 Sep 2023

Sponsor / Collaborator

Shenzhen Sixth People's Hospital

TCTR20240830005

/ CompletedPhase 1/2IIT

Comparison of the efficacy of 0.12% chlorhexidine mouthwash containing 0.001% EDTA and commercially available 0.12% chlorhexidine mouthwash: A randomized clinical trial

Start Date11 Feb 2023

Sponsor / Collaborator

University of Chulalongkorn

NCT06597825

/ CompletedNot ApplicableIIT

Antibacterial Effect of Sodium Hypochlorite Combined With Etidronic Acid in Apical Periodontitis Treatment: A Prospective, Single Blinded, Randomised Clinical Trial

Sodium hypochlorite (NaOCl), the most commonly used irrigation solution during chemomechanical preparation, plays a significant role in eliminating bacteria within root canals. Additionally, after preparation with different concentrations of NaOCl, 30% to 70% resistant bacteria were observed in the root canals. For this reason, new protocols have been developed to increase the effectiveness of NaOCl in chemomechanical preparation and to support disinfection within root canals. Recently, etidronic acid (1-hydroxyethane 1,1-diphosphonic acid [HEDP]), a biocompatible chelating agent, has emerged as an alternative irrigation solution. It has been suggested to combine and use this solution with NaOCl.
This study aims to evaluate the antimicrobial effectiveness of NaOCl in the root canal, which is used in combination with HEDP or sequentially with Ethylenediaminetetraacetic acid (EDTA) in the final irrigation after retreatment. Additionally, the effect of activation with Endoactivator (EA) on microbial reduction was assessed.

Start Date17 Aug 2020

Sponsor / Collaborator

Mustafa Kemal University

100 Clinical Results associated with Disodium edetate

100 Translational Medicine associated with Disodium edetate

100 Patents (Medical) associated with Disodium edetate

52,256

Literatures (Medical) associated with Disodium edetate

31 Dec 2025·Energy Sources, Part A: Recovery, Utilization, and Environmental Effects

A model of eco-friendly cooking stove and a potential application of soot for remediation of heavy metals in the environment

Author: Fatima, Raveen ; Iram, Shazia

The aim of this paper is twofold.Firstly, we present a model of an eco-friendly cooking stove to overcome the problem of domestic soot emissions.The proposed model of stove uses a typical type of vented soot filtration hood which contains the soot particulate filters to effectively control soot emissions.Secondly, we study the remediation efficiency of plastic fuel derived soot for heavy metals lead (Pb), nickel (Ni), and chromium (Cr) from the aqueous solutions, contaminated soil, and wastewater samples.A series of batch adsorption experiments are conducted to analyze the effect of different parameters on the heavy metals uptake from aqueous solutions and wastewater samples.Exptl. results reveal that pH 9.0 is optimal for the adsorption of heavy metals from the aqueous solutionsSoot application to the soil samples increased the pH and reduced 0.1 M EDTA extractable concentration of heavy metals.From the water samples, adsorption of heavy metals increased by increasing the contact time and maximum adsorption occurred at the optimum contact time of 3 h.The overall effectiveness of soot in reducing the concentration of heavy metals from aqueous solutions, soil samples, and water samples is as follows: Pb (94.4%, 75%, and 90.5%), Ni (69.97%, 37.4%, and 69.8%), and Cr (61.3%, 37.5%, and 82.6%).It has been inferred from results of this study that soot has a great potential as a remediation tool for the environment excessively contaminated with heavy metals.

01 Sep 2025·Water Research X

Research on the influence of g-C3N4 microstructure changes on the efficiency of visible light photocatalytic degradation

Author: Guo, Renjiang ; Tian, Bihong ; Wu, Jian ; Zhao, Zhichao ; Wang, Ya ; Tu, Hong ; Chen, Shunhong

The structural modulation of pristine graphitic carbon nitride poses a considerable challenge in the rational design of catalysts for the efficient degradation of small organic pollutants under visible light.In this study, we combined first-principles calculations and the structure-function relationship to predict a high-performance catalyst.The results reveal that CN-8 demonstrates a remarkable degree of electron-hole separationNotably, CN-8 shows exceptional degradation efficiency towards rhodamine B, tetracycline, bisphenol A, and fluralaner under visible light irradiationSpecifically, the degradation rate constants are 11, 4, 12, and 32 times higher, resp., compared to bulk g-C₃N₄.Through d. functional theory calculations and investigations of the structure-function relationship, it is confirmed that the superior catalytic activity of CN-8 lies in modifying the amino position, which alters the electron cloud distribution and promotes the efficient separation of photo-generated electron-hole pairs.This study provides valuable insights for the development of eco-friendly and efficient photocatalysts for environmental remediation.

01 Jul 2025·Separation and Purification Technology

EDTA ligand and photocatalyst CoO @F-TiO2 enhance NO removal from flue gas by H2O2/Fe(Ⅲ) Fenton reaction

Author: Liu, Lingtao ; Li, Jiawei ; He, Feiqiang ; Li, Zhuyao ; Xu, Yuan ; Ouyang, Jinbo ; Dai, Ying ; Ding, Jianhua ; Gao, Zhi ; Lin, Xinhui

Iron precipitation and the Fe(III)/Fe(II) cycle have become bottlenecks that urgently need to be addressed in the wet Fenton denitrification.For this purpose, EDTA ligand and photocatalyst CoOx@F-TiO₂, synthesized by crystal facet engineering and selective photodeposition, were combined with H₂O₂/Fe(III) with UV light (UV) to develop a new Fenton system (H₂O₂/Fe(III)EDTA/UV/CoOx@F-TiO₂) for NO removal.The findings indicated that the combination of EDTA and CoOx@F-TiO₂ can greatly enhance the elimination of NO using H₂O₂/Fe(III) under UV light exposure, resulting in a removal effectiveness of _82.42% on averageThe mechanism investigation showed that the superior removal performance was primarily attributable to the ability of CoOx@F-TiO₂ to significantly reduce the rate of electron-hole recombination, speed up the Fe(III)/Fe(II) cycle, and continuously produce .OH, which improved the oxidative removal of NO.In simulated flue gas treatment processes, the predominant transformation pathways for NO were observed to yield nitrate, nitrite, ammonium, and nitrogen under multiple chem. reactions.In addition, NO removal performance and kinetic anal. by H₂O₂/Fe(III)EDTA/UV/CoOx@F-TiO₂ under varying operational conditions were investigated.This study presents an innovative method for the environmentally friendly and resource-saving Fenton denitrification in the treatment of flue gas.

News (Medical) associated with Disodium edetate

13 Sep 2024

·www.biospace.com

Rising Pharmaceuticals announces commercial availability of Edetate calcium disodium injection in the United States

Rising’s Edetate calcium disodium injection is FDA-approved and immediately available Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. 1 EAST BRUNSWICK, N.J.--(BUSINESS WIRE)-- #adultleadpoisoning --Rising Pharma Holdings, Inc., d/b/a Rising Pharmaceuticals, Inc. (“Rising”) announced commercial availability of Edetate calcium disodium injection. Access to Rising’s product continues despite a commercial shortage of this product in the United States. Rising’s Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. “Rising’s Edetate calcium disodium injection provides an available option for health care providers to treat patients exposed to lead poisoning,” said David Picard, Executive Vice President for Institutional Markets at Rising. “This continued availability reflects our ongoing commitment to addressing product supply shortages to help ensure health care providers have access to products for patient care.” Edetate Calcium Disodium injection, USP 5 mL single-dose vial containing 200 mg of edetate calcium disodium per mL (1000 mg per vial) Supplied in boxes containing 5 vials (NDC 64980-588-51) Wholesale Item Numbers Cardinal 5855416 Cencora 10291753 Mckesson 2830826 Morris Dickson 296285 ___________________________ 1 Full prescribing information and label available at and provided below. About Rising Pharmaceuticals, Inc. Rising Pharmaceuticals, Inc. is a leading provider of generic and specialty-branded pharmaceuticals in the U.S. Rising focuses on the development, regulatory, and commercial aspects of the product life cycle while outsourcing manufacturing to its network of strategic CMO and CDO partners. With over 182 commercialized generic medicines and over 620 active SKUs, Rising has one of the largest portfolios of any generic pharmaceutical company in the US market. Through an extensive global network of manufacturing facilities, Rising supplies almost 9 billion doses of generic medicine to the market annually. The Company is based in New Brunswick, New Jersey. For more information about the Company, please visit . Edetate Calcium Disodium Injection, USP Intravenous or Intramuscular Use Rx Only WARNINGS Edetate calcium disodium injection is capable of producing toxic effects which can be fatal. Lead encephalopathy is relatively rare in adults, but occurs more often in pediatric patients in whom it may be incipient and thus overlooked. The mortality rate in pediatric patients has been high. Patients with lead encephalopathy and cerebral edema may experience a lethal increase in intracranial pressure following intravenous infusion; the intramuscular route is preferred for these patients. In cases where the intravenous route is necessary, avoid rapid infusion. The dosage schedule should be followed and at no time should the recommended daily dose be exceeded. DESCRIPTION Edetate Calcium Disodium injection, USP is a sterile, injectable, chelating agent in concentrated solution for intravenous infusion or intramuscular injection. Each 5 mL single-dose vial contains 1000 mg of edetate calcium disodium (equivalent to 200 mg/mL) in water for injection and sodium hydroxide (as pH adjuster). Chemically, this product is called [[N,N'-1,2-ethanediyl-bis[N-(carboxymethyl)-glycinato]](4-)-N,N’,O,O’,ON,ON’]-, disodium, hydrate, (OC-6-21)-Calciate(2-). CLINICAL PHARMACOLOGY The pharmacologic effects of edetate calcium disodium are due to the formation of chelates with divalent and trivalent metals. A stable chelate will form with any metal that has the ability to displace calcium from the molecule, a feature shared by lead, zinc, cadmium, manganese, iron and mercury. The amounts of manganese and iron mobilized are not significant. Copper1 is not mobilized and mercury is unavailable for chelation because it is too tightly bound to body ligands or it is stored in inaccessible body compartments. The excretion of calcium by the body is not increased following intravenous administration of edetate calcium disodium, but the excretion of zinc is considerably increased.1 Edetate calcium disodium is poorly absorbed from the gastrointestinal tract. In blood, all the drug is found in the plasma. Edetate calcium disodium does not appear to penetrate cells; it is distributed primarily in the extracellular fluid with only about 5% of the plasma concentration found in spinal fluid. The half life of edetate calcium disodium is 20 to 60 minutes. It is excreted primarily by the kidney, with about 50% excreted in one hour and over 95% within 24 hours.2 Almost none of the compound is metabolized. The primary source of lead chelated by edetate calcium disodium is from bone; subsequently, soft-tissue lead is redistributed to bone when chelation is stopped.3,4 There is also some reduction in kidney lead levels following chelation therapy. It has been shown in animals that following a single dose of edetate calcium disodium urinary lead output increases, blood lead concentration decreases, but brain lead is significantly increased due to internal redistribution of lead.5 (See WARNINGS .) These data are in agreement with the recent results of others in experimental animals showing that after a five day course of treatment there is no net reduction in brain lead.6 INDICATIONS AND USAGE Edetate calcium disodium injection is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead. CONTRAINDICATIONS Edetate calcium disodium injection should not be given during periods of anuria, nor to patients with active renal disease or hepatitis. WARNINGS See boxed warning . PRECAUTIONS General Precautions Edetate calcium disodium may produce the same renal damage as lead poisoning, such as proteinuria and microscopic hematuria. Treatment-induced nephrotoxicity is dose-dependent and may be reduced by assuring adequate diuresis before therapy begins. Urine flow must be monitored throughout therapy which must be stopped if anuria or severe oliguria develop. The proximal tubule hydropic degeneration usually recovers upon cessation of therapy. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Patients should be monitored for cardiac rhythm irregularities and other ECG changes during intravenous therapy. Information for patients Patients should be instructed to immediately inform their physician if urine output stops for a period of 12 hours. Laboratory tests Urinalysis and urine sediment, renal and hepatic function and serum electrolyte levels should be checked before each course of therapy and then be monitored daily during therapy in severe cases, and in less serious cases after the second and fifth day of therapy. Therapy must be discontinued at the first sign of renal toxicity. The presence of large renal epithelial cells or increasing number of red blood cells in urinary sediment or greater proteinuria call for immediate stopping of edetate calcium disodium administration. Alkaline phosphatase values are frequently depressed (possibly due to decreased serum zinc levels), but return to normal within 48 hours after cessation of therapy. Elevated erythrocyte protoporphyrin levels (> 35 mcg/dl of whole blood) indicate the need to perform a venous blood lead determination. If the whole blood lead concentration is between 25 to 55 mcg/dl a mobilization test can be considered.7,8 (See Diagnostic Test .) An elevation of urinary coproporphyrin (adults: > 250 mcg/day; pediatric patients under 80 lbs: > 75 mcg/day) and elevation of urinary delta aminolevulinic acid (ALA) (adults: > 4 mg/day; pediatric patients: > 3 mg/m2/day) are associated with blood lead levels > 40 mcg/dl. Urinary coproporphyrin may be falsely negative in terminal patients and in severely iron-depleted pediatric patients who are not regenerating heme.9 In growing pediatric patients long bone x-rays showing lead lines and abdominal x-rays showing radio-opaque material in the abdomen may be of help in estimating the level of exposure to lead. Drug Interactions There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of edetate calcium disodium in animals.7 Edetate calcium disodium interferes with the action of zinc insulin preparations by chelating the zinc.7 Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been conducted with edetate calcium disodium to evaluate its carcinogenic potential, mutagenic potential or its effect on fertility. Pregnancy Category B One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to edetate calcium disodium.10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to edetate calcium disodium, which were prevented by simultaneous supplementation of dietary zinc.11 There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Labor and Delivery Edetate calcium disodium has no recognized use during labor and delivery, and its effects during these processes are unknown. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when edetate calcium disodium is administered to a nursing woman. Pediatric Use Since lead poisoning occurs in pediatric populations and adults but is frequently more severe in pediatric patients, edetate calcium disodium is used in patients of all ages. The intramuscular route is preferred by some for young pediatric patients. In cases where the intravenous route is necessary, avoid rapid infusion. (See WARNINGS .) Urine flow must be monitored throughout therapy; Edetate Calcium Disodium therapy must be stopped if anuria or severe oliguria develops. (See General Precautions .) At no time should the recommended daily dosage be exceeded. (See DOSAGE AND ADMINISTRATION .) ADVERSE REACTIONS The following adverse effects have been associated with the use of edetate calcium disodium: Body as a Whole: pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia. Cardiovascular: hypotension, cardiac rhythm irregularities. Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli. Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment. Nervous System: tremors, headache, numbness, tingling. Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst. Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy. Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash. Hematopoietic: transient bone marrow depression, anemia. Metabolic: zinc deficiency, hypercalcemia. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or . OVERDOSAGE Symptoms Inadvertent administration of 5 times the recommended dose, infused intravenously over a 24 hour period, to an asymptomatic 16 month old patient with a blood lead content of 56 mcg/dl did not cause any ill effects. Edetate calcium disodium can aggravate the symptoms of severe lead poisoning, therefore, most toxic effects (cerebral edema, renal tubular necrosis) appear to be associated with lead poisoning. Because of cerebral edema, a therapeutic dose may be lethal to an adult or a pediatric patient with lead encephalopathy. Higher dosage of edetate calcium disodium may produce a more severe zinc deficiency. Treatment Cerebral edema should be treated with repeated doses of mannitol. Steroids enhance the renal toxicity of edetate calcium disodium in animals and, therefore, are no longer recommended.7 Zinc levels must be monitored. Good urinary output must be maintained because diuresis will enhance drug elimination. It is not known if edetate calcium disodium is dialyzable. DOSAGE AND ADMINISTRATION When a source for the lead intoxication has been identified, the patient should be removed from the source, if possible. The recommended dose of edetate calcium disodium for asymptomatic adults and pediatric patients whose blood lead level is 20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m2/day whether given intravenously or intramuscularly. (See Surface Area Nomogram.) For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m2 every 24 hours for 5 days for patients with serum creatinine levels of 2 to 3 mg/dl, every 48 hours for 3 doses for patients with creatinine levels of 3 to 4 mg/dl, and once weekly for patients with creatinine levels above 4 mg/dl. These regimens may be repeated at one month intervals.12 Edetate calcium disodium, used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is > 70 mcg/dl or clinical symptoms consistent with lead poisoning are present, it is recommended that edetate calcium disodium be used in conjunction with BAL (dimercaprol). Please consult published protocols and specialized references for dosage recommendations of combination therapy.14-18 Therapy of lead poisoning in adults and pediatric patients with edetate calcium disodium is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient’s tolerance of the drug. Edetate calcium disodium is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients. Acutely ill individuals may be dehydrated from vomiting. Since edetate calcium disodium is excreted almost exclusively in the urine, it is very important to establish urine flow with intravenous fluid administration before the first dose of the chelating agent is given; however, excessive fluid must be avoided in patients with encephalopathy. Once urine flow is established, further intravenous fluid is restricted to basal water and electrolyte requirements. Administration of edetate calcium disodium should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Intravenous Administration Add the total daily dose of edetate calcium disodium (1000 mg/m2/day) to 250-500 mL of 5% dextrose or 0.9% sodium chloride injection. The total daily dose should be infused over a period of 8 to 12 hours. Discard unused portion. Edetate calcium disodium injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer’s, Ringer’s, one-sixth molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride. Intramuscular Administration The total daily dosage (1000 mg/m2/day) should be divided into equal doses spaced 8 to 12 hours apart. Discard unused portion. Lidocaine or procaine should be added to the edetate calcium disodium injection to minimize pain at the injection site. The final lidocaine or procaine concentration of 5 mg/mL (0.5%) can be obtained as follows: 0.25 mL of 10% lidocaine solution per 5 mL concentrated edetate calcium disodium; 1 mL of 1% lidocaine or procaine solution per mL of concentrated edetate calcium disodium. When used alone, regardless of method of administration, edetate calcium disodium should not be given at doses larger than those recommended. Diagnostic Test Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores.7, 9,12,13,18 These procedures have advantages and disadvantages that should be reviewed in current references. Edetate calcium disodium mobilization tests should not be performed in symptomatic patients and in patients with blood lead levels above 55 mcg/dl for whom appropriate therapy is indicated. Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. HOW SUPPLIED Edetate Calcium Disodium injection, USP 5 mL single-dose vial (NDC 64980-588-05 ) containing 200 mg of edetate calcium disodium per mL (1000 mg per vial), in boxes containing 5 vials (NDC 64980-588-51 ). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx Only This product is non-returnable. REFERENCES 1. Thomas DJ, Chisolm JJ. Lead, zinc and copper decorporation during calcium disodium ethylene diamine tetraacetate treatment of lead-poisoned children. J Pharmacol Exp Therapeu 1986; 239: 829–835. 2. The Pharmacological Basis of Therapeutics, 7th edition, Goodman and Gilman, editors. MacMillan Publishing Company, New York, 1985, pp. 1619–1622. 3. Hammond PB, Aronson AL, Olson WC. The mechanism of mobilization of lead by ethylenediaminetetraacetate. J Pharmacol Exp Therapeu 1967; 157: 196–206. 4. Van deVyver FL, D’Haese PC, Visser WJ, et al. Bone lead in dialysis patients. Kidney Intl 1988; 33: 601–607. 5. Cory-Slecta DA, Weiss B, Cox C. Mobilization and redistribution of lead over the course of calcium disodium ethylene diamine tetraacetate chelation therapy. J Pharmacol Exp Therapeu 1987; 243: 804–813. 6. Chisolm JJ. Mobilization of lead by calcium disodium edetate. Am J Dis Child 1987;141: 1256–1257. 7. Drug Evaluations, 6th Edition, American Medical Association, Saunders, Philadelphia, 1986, pp. 1637–1639. 8. Centers for Disease Control: Preventing lead poisoning in young children. Atlanta, GA, Department of Health and Human Services, 1985 Jan. 9. Finberg L, Rajagopal V. Diagnosis and treatment of lead poisoning in children. J Family Med 1985 April: 3–12. 10. Schardein JL, Sakowski R, Petrere J, et al. Teratogenesis studies with EDTA and its salts in rats. Toxicol Appl Pharmacol 1981; 61: 423–428. 11. Swenerton H, Hurley LS. Teratogenic effects of a chelating agent and their prevention by zinc. Science 1971; 173: 62–64. 12. American Hospital Formulary Service, Drug Information, 1988, pp. 1695–1698. 13. Markowitz ME, Rosen JF. Assessment of lead stores in children: Validation of an 8-hour CaNa2EDTA (Edetate Calcium Disodium) provocative test. J Pediatrics 1984;104: 337–341. 14. Piomelli S, Rosen JF, Chisolm JJ, et al. Management of childhood lead poisoning. J Pediatrics 1984; 105: 523–532. 15. Sachs HK, Blanksma LA, Murray EF, et al. Ambulatory treatment of lead poisoning: Report of 1,155 cases. Pediatrics 1970; 46: 389. 16. Chisolm JJ. The use of chelating agents in the treatment of acute and chronic lead intoxication in childhood. J Pediatrics 1968; 73: 1. 17. Coffin R, Phillips JL, Staples WI, et al. Treatment of lead encephalopathy in children. J Pediatrics 1966; 69: 198–206. 18. Chisolm JJ. Increased lead absorption and acute lead poisoning. Current Pediatric Therapy 12, Gillis and Kagan, editors, WB Saunders, Philadelphia, 1986, pp. 667–671. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816. Made in India Contacts For Media Inquiries: Marina Wissa, (201) 961 9013 mediainquiries@risingpharma.com For Customer Service Inquiries: Jason Eisner, (201) 961 9000 customerservice@risingpharma.com

Clinical ResultDrug Approval

07 May 2024

·www.medicaldesignandoutsourcing.com

This medtech developer is throwing everything at clots

Retriever Medical is developing a thrombectomy system with a four-front approach for treating blood clots. The Las Vegas-based startup calls its technology VORS AMD, for vascular occlusion removal system with aspiration, mechanical and drug delivery. The approach combines nitinol baskets for mechanical thrombectomy with aspiration, clot-busting drugs and blood filtration for reinfusion. “This is a seminal approach — a seminal design,” Retriever Medical co-founder, President and CEO Ben Bobo said in an interview. “… There’s nobody quite doing it the way we’re doing it. And I think this design will prove itself to probably be the most effective on the market.” Retriever Medical’s devices in development include the ClotHound ACE Blue and Gold mechanical thrombectomy catheters for deep vein thrombosis (ACE Blue) and pulmonary embolism (ACE Gold). These catheters each have two spherical baskets for physically grabbing, breaking up and removing clots — and they could someday elute clot-busters and other drugs. Retriever Medical is also developing aspiration catheters to work with the ClotHounds. The DogTail catheter is a 16-French aspiration catheter for use with ClotHound ACE Blue, while the large-bore DogLeg (24-French) and DogCurve (20-French) aspiration catheters are designed to work with ClotHound ACE Gold. On top of that, Retriever Medical designed the BloodHound BOSS (blood saver system) to collect, filter and reinfuse blood removed from a patient during aspiration. Designing Retriever Medical’s system The ClotHound Ace Blue and Gold catheters each have two independent, adjustable nitinol spheres with fixed-diameter controllers, allowing a physician to move one of the spheres back and forth for curettage to dislodge stubborn clots, with the aspiration catheter removing the remaining bits, said Retriever Medical R&D VP Hieu Le. “In developing thrombectomy technology for over 20 years, I do believe that Retriever has a chance to work on sub-acute and chronic clot — basically scrubbing it and removing it so that we can aspirate it out with the aspiration catheter,” he said. “… You need to remove it from the wall and break it down into small particles so that the aspiration can suck it out.” The distal sphere blocks bits of clot from escaping, acting as an “anchoring mechanism that provides embolic protection while you work on this tenacious clot” with the proximal sphere, Bobo said. ClotHound ACE Blue for deep vein thrombosis has a slightly larger distal sphere to accommodate the increasing size of the vein as you approach the heart, Le said, while the ClotHound ACE Gold’s sphere’s are identical in size. The two catheters also differ in length, inner diameter and outer diameter, but are otherwise essentially the same. “In my mind, I’m developing one system,” Le said. Rather than relying on nitinol’s superelastic properties to passively self-expand the baskets when they exit the catheter, ClotHound lets a physician control the expansion to force its way through particularly thick, impacted clots. Those braided nitinol spheres can be expanded in 0.1 mm increments to fit blood vessels of various diameters and maintain their shape. The spheres have a rounded wire design rather than a flat wire to minimize trauma to the endothelial lining of the blood vessel. “The other thing it does is distributes the load as you start to expand it,” Bobo said. “Let’s say you have an 8 mm vessel. The sphere will go oblong-shaped like a football so it spreads the force along the whole section of the vessel as we curettage it. What we found is it really has minimal to no impact on the vessel wall, but it’s really great at engaging the clot.” The design of the two ClotHound devices is identical for muscle memory proficiency to accelerate use by physicians, Bobo said. “When you go to use a device and you start to drive adoption, it’s much easier if they understand the functionality is the same whether it be removing a clot from the lungs or the legs,” he said. The aspiration catheters use laser-cut stainless steel hypotube to avoid kinking or ovalization to maximize aspiration flow. The catheters have an inner layer of polytetrafluoroethylene (PTFE) and an outer layer of a polyurethane hybrid similar to polyvinyl acetate (PVA). Laser-cut hypotube is more expensive than braided or coil approaches, but “we thought it was worth the trade off in performance,” Bobo said. Retriever Medical used off-the-shelf components to accelerate prototyping, and then modified them — grinding hypotube down by a few thousandths of an inch to reduce the wall thickness, for example. “The overall goal is that we try to utilize what is out there and try to minimize invention because we want to go fast, which we are,” Le said. “We utilize what’s out there — off-the-shelf or readily available technology — and put it together into the patent recipe that we have to make it unique.” Pairing the clot-catching ClotHound baskets with aspiration allows a physician to leave the mechanical thrombectomy catheter inside the patient between passes, with the aspiration catheter clearing the clot that the ClotHound caught. That gravity-fed BloodHound system passes clot blood through an initial ThromboGuard filter with 2 mm inlet holes, then through a 250-micron ThromboScreen filter and a 40-micron MicroGuard filter and into a reservoir for reinfusion back into the patient. “If you want me to use your catheter you need to give me a blood reinfusion device, because if I’m pulling out blood, I want to give it back,” Bobo recalls one physician telling him about the system, leading to the BloodHound project. Retriever Medical wants to use injection ports on the spheres to break up clots with anticoagulant ethylenediaminetetraacetic acid (EDTA). Adding clot-busting drugs to the system “takes it to a whole other level,” Bobo said. Retriever Medical also wants to incorporate a drug-eluting coating on the spheres for polyglycerol sebacate (PGS), anti-inflammatory agents, stem cells, modulators, lytics or other drugs. What’s next for Retriever Medical Retriever Medical is on track for a design freeze and the start of verification and validation in 2024 and to submit for FDA 510(k) clearance in 2026, Bobo and Le said. That doesn’t include the drug elution approach due to the different regulatory path for drug-device combinations, but Retriever is keeping that vision during product development. “That’s going to be really where the future is,” Bobo said. “People are just thinking in terms of mechanical, aspiration — pharmacological will be an important addition to the procedure.”

09 Oct 2023

·www.biospace.com

Fresenius Kabi Introduces Smart Labels for Diprivan® with Embedded Fully Interoperable +RFID Technology

Now compatible with all major RFID kit and tray systems LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced +RFID smart labels for Diprivan® (Propofol) Injectable Emulsion, USP, 200 mg per 20 mL in single-dose vials, sold in the United States. The +RFID labels are now fully compatible with all major RFID kit and tray systems in the U.S. This press release features multimedia. View the full release here: Fresenius Kabi Diprivan® (Propofol) Injectable Emulsion, USP, 200 mg per 20 mL in single-dose vials, now compatible with all major RFID kit and tray systems. (Photo: Business Wire) The launch expands Fresenius Kabi’s industry-leading +RFID portfolio of fully interoperable labeled medications. The use of radio-frequency identification (RFID) label technology eliminates the need to tag medicines manually which saves time and supports a safe, more efficient medication inventory process. Fresenius Kabi is the first pharmaceutical manufacturer to adopt GS1's EPC Tag Data Standard (TDS) to enhance interoperability. GS1 Standards for identifying, capturing and sharing supply chain data help ensure product and inventory information is accessible, accurate and easy to understand. Diprivan, the most prescribed propofol anesthetic in the U.S.1, was the first Fresenius Kabi product introduced with RFID labels in 2020 for use with some RFID kit and tray systems. The drug is now certified for use with all RFID systems and is available immediately to order through wholesalers and direct from Fresenius Kabi. To meet the highest standards of performance and quality, in addition to the company’s own testing, Diprivan +RFID has been tested by the Axia Institute of Michigan State University and certified by the ARC RFID lab of Auburn University. Fresenius Kabi is expanding its portfolio of fully compatible +RFID products based on demand from hospitals. In a recent study by the ASHP Foundation, nearly nine in 10 hospitals that participated reported they are already using RFID technology or are evaluating it. “We are dedicated to supporting our customers in the adoption of RFID technology that enhances patient care, improves efficiency and streamlines workflows for pharmacists,” said John Ducker, president and CEO of Fresenius Kabi USA. The company has also released newly labeled Vasopressin Injection, USP 20 units per 1 mL in single-dose vials with +RFID smart labels, adding to the company’s growing portfolio of products compatible with all major RFID kit and tray systems. About Diprivan® (Propofol), Injectable Emulsion, USP Indications and Usage – DIPRIVAN® (Propofol), Injectable Emulsion, USP is an intravenous general anesthetic and sedation drug for use in adults for initiation and maintenance of Monitored Anesthesia Care (MAC) sedation, combined sedation and regional anesthesia, and Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients. DIPRIVAN is also indicated for induction of general anesthesia for patients greater than or equal to 3 years of age and for maintenance of general anesthesia for patients greater than or equal to 2 months of age. Important Safety Information DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components, and also in patients with allergies to eggs, egg products, soybeans or soy products. DIPRIVAN is not indicated for use in pediatric patients for ICU sedation or for MAC sedation for surgical, nonsurgical or diagnostic procedures as safety and effectiveness have not been established. DIPRIVAN is not recommended for induction of anesthesia in patients below the age of 3 years or for maintenance of anesthesia in patients below the age of 2 months because its safety and effectiveness have not been established in those populations. Use of DIPRIVAN has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension occur rarely following DIPRIVAN administration. Strict aseptic technique must always be maintained during handling. DIPRIVAN is a single access parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Failure to use aseptic technique when handling DIPRIVAN was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. A DIPRIVAN vial is never to be accessed more than once or used on more than one person. DIPRIVAN has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with DIPRIVAN. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. Diprivan should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. Administer DIPRIVAN with caution in patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis. Very rarely the use of DIPRIVAN may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. When DIPRIVAN is administered to an epileptic patient, there is a risk of seizure during the recovery phase. Attention should be paid to minimize pain on administration of Diprivan. Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (less than 1%). Perioperative myoclonia, rarely including convulsions and opisthotonos, has occurred in association with DIPRIVAN administration. Rarely, cases of unexplained postoperative pancreatitis (requiring hospital admission) have been reported after anesthesia in which DIPRIVAN was one of the induction agents used. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Patients should be continuously monitored for early signs of significant hypotension and/or cardiovascular depression, which may be profound. Abrupt discontinuation of DIPRIVAN prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. In pediatric patients, abrupt discontinuation of DIPRIVAN following prolonged infusion may result in flushing of the hands and feet, agitation, tremulousness and hyperirritability. Increased incidences of bradycardia, agitation, and jitteriness have also been observed. For both adult and pediatric ICU sedation, DIPRIVAN infusion has been associated with Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes and/or cardiac failure. Since DIPRIVAN is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when DIPRIVAN is administered for extended periods of time. Patients at risk of hyperlipidemia should be monitored for increases in serum triglycerides or serum turbidity. EDTA is a strong chelator of trace metals – including zinc. DIPRIVAN should not be infused for longer than 5 days without providing a drug holiday to safely replace estimated or measured urine zinc losses. At high doses (2 grams to 3 grams per day), EDTA has been reported, on rare occasions, to be toxic to the renal tubules. Monitor patients at risk for renal impairment. There have been rare reports of pulmonary edema in temporal relationship to the administration of DIPRIVAN, although a causal relationship is unknown. Neurosurgical Anesthesia: When DIPRIVAN is used in patients with increased intracranial pressure or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decrease in cerebral perfusion pressure. Cardiac Anesthesia: Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shifts, and patients who are hemodynamically unstable. Pediatric Neurotoxicity: Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is unclear. Adverse reactions reported with an incidence greater than 1% were: bradycardia, arrhythmia, tachycardia, hypotension, decreased cardiac output, hypertension, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . DIPRIVAN is not recommended for obstetrics, including Cesarean section deliveries. DIPRIVAN crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN may be associated with neonatal depression. DIPRIVAN is not recommended for use in nursing mothers because Propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known. This Important Safety Information does not include all the information needed to use DIPRIVAN® (Propofol), Injectable Emulsion, USP safely and effectively. Please see full prescribing information for DIPRIVAN® (Propofol), Injectable Emulsion, USP at . References 1. Data on file. About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn.

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D00052	Disodium edetate	V03AB03	DB00974

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02733185 (TACT2, CTgov)	Phase 3	Myocardial Infarction \| Diabetes Mellitus	1,000	Oral Multi Vitamins/Minerals (OMVM)+disodium EDTA (Active/Active)	yduqlecpdy(odmqykyums) = sbpnfuhyoj nvcjwraomd (rtqycqtkbj, gzwepulmoy - udtrllkcuh) View more	-	01 Oct 2024
				disodium EDTA (Active/Placebo)	yduqlecpdy(odmqykyums) = ohttuivefo nvcjwraomd (rtqycqtkbj, neyudvcfke - ywcnfeugwo) View more
NCT02733185 (TACT2, Pubmed \| JAMA)	Phase 3	Old myocardial infarction	959	EDTA-based chelation solution	setxgarwrv(nvaewkkqlz) = ibwmezgiso zebxubryam (pqmknmyewh ) View more	Negative	14 Aug 2024
				Placebo infusion	setxgarwrv(nvaewkkqlz) = tkgzphrrbo zebxubryam (pqmknmyewh ) View more
ARVO2011	Not Applicable	Capsule Opacification	-	EDTA @5mg/ml	dvyxyiqaey(vupcxfbxiz) = sfcnvemymw vuojvlmnxh (ohtonkztlt ) View more	-	01 Apr 2011
				Doxycyclin @ 1mg/ml	dvyxyiqaey(vupcxfbxiz) = tkffrgxjcb vuojvlmnxh (ohtonkztlt ) View more
ARVO2003	Not Applicable	Corneal Dystrophy, Band-Shaped	224	EDTA Chelation	(beplguknua) = ukhjwodchj yqkcakjdyy (tqbhqerljp ) View more	Positive	01 May 2003
				EDTA Chelation (Medical Treatment)	(beplguknua) = nfkfrhoaaq yqkcakjdyy (tqbhqerljp ) View more

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