Embolism, Air

CENTER VALLEY, Pa., March 1, 2024 /PRNewswire/ -- Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today that EndoClot products are now used in 49 of the 50 U.S. states as well as the District of Columbia and Guam, since Olympus became the exclusive U.S. distributor of EndoClot hemostatis and submucosal injection solution technologies in 2022. Continue Reading EndoClot products are used by more than 700 accounts, including most of the country’s top-ranked (by size) Integrated Delivery Networks (IDNs) More than 5,000 EndoClot kits have been shipped to customers to date. EndoClot products are used by more than 700 accounts, including most of the country's top-ranked (by size) Integrated Delivery Networks (IDNs). Since their launch, EndoClot products have been discussed in close to 20 relevant professional education courses offered via Olympus Continuum, providing physicians with peer-demonstrations of EndoClot technology capabilities during procedures. "Olympus knew that EndoClot technology would be important to improving procedure efficiencies and contributing to improved patient outcomes," said Patrick Romano, Vice President, GI Business Unit Leader, Olympus Corporation of the Americas. "But we are nevertheless impressed with the traction that the products have gained in such a short time. The team has been focused on EndoClot since its commercial launch because identifying and treating GI bleeds have been problems in need of optimized solutions for some time." The EndoClot® Polysaccharide Hemostatic Spray (PHS) and EndoClot® Submucosal Injection Solution (SIS) were developed by EndoClot Plus, Inc. (EPI), which joined with Olympus in a U.S. distribution agreement in 2022, extending upon an earlier agreement in the EMEA region. EndoClot PHS and SIS became commercially available in the U.S. in September 2022 and in the Europe, Middle East and Africa (EMEA) region in April 2023. Both products are based on the EndoClot Absorbable Modified Polymer (AMP®) technology, which has demonstrated an excellent safety profile.1 The EndoClot AMP particles work by absorbing water from blood. The dehydration process causes a high concentration of platelets, red blood cells and coagulation proteins, which helps accelerate the body's clotting cascade. AMP particles are biocompatible, bioabsorbable, non-pyrogenic, starch derived and contain no animal or human components.1 "I have been an EndoClot technology user, both PHS and SIS, from almost as soon as it was available, and I am pleased with the results," said Ahmed Saeed, MD, Premier Gastroenterology of Kansas City, Overland Park, Kansas.* "Patients deserve the technology that can prevent complications from becoming more emergent and requiring follow-up care." The EndoClot PHS System enables physicians to apply an advanced powder hemostat during a procedure using controlled, consistent air pressure through a portable air compressor. Used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding, the EndoClot PHS System1: Is indicated for use within the gastrointestinal (GI) tract and in combination with other conventional techniques, like clipping, for large and diffuse bleeds, such as those occurring in peptic ulcers, post-biopsy, polypectomy, tumor bleeding, as well as post-EMR and ESD; Allows for easy irrigation with water during procedures; Provides control of delivery and anti-reflux capability through the applicator design, which can prevent occlusion and treat hard-to-reach bleeds; and Features an air compressor of small, portable design and provides consistent air pressure to propel powder to the bleeding site, while helping prevent the white-out effect common with CO2 propellant. Performing hemostasis within the GI tract is a technically demanding procedure and the use of EndoClot PHS and associated devices may result in patient injury including but not limited to inflammatory reaction, bowel rupture and air embolism. EndoClot PHS is not indicated for use in surgical or trauma applications. The EndoClot SIS System is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. The EndoClot SIS solution1: Provides a long-lasting, high lift that may create significant mucosal separation allowing for easy dissection; Accurately delivers to the targeted area owing to use of a specialized spiral syringe design; and Minimizes residual artifacts that may cause abnormalities during pathological investigations. Use of a lifting agent during EMR/ESD/POEM and difficult polypectomy and the associated devices may result in patient injury, bleeding and/or perforation. For more information visit the EndoClot PHS and EndoClot SIS product pages. A new video highlighting use of the EndoClot PHS and EndoClot SIS has been developed to provide more information: . 1. Data on file with Olympus as of 16/Aug/2022 *Dr. Saeed is a paid consultant to Olympus. About Olympus At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals striving to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit medical.olympusamerica.com. SOURCE Olympus Corporation of the Americas

MONDAY, Jan. 29, 2024 -- For percutaneous lung ablation, high-frequency jet ventilation (HFJV) under general anesthesia seems as safe as spontaneous respiration (SR) under moderate sedation, with longer room time for HFJV, according to a study published online Jan. 24 in the American Journal of Roentgenology . Alexander Graur, from Massachusetts General Hospital in Boston, and colleagues conducted a retrospective study involving consecutive adults who underwent computed tomography (CT)-guided percutaneous cryoablation of one or more lung tumors with HFJV or SR. Major adverse events within 30 days and hospital length of stay (HLOS) at least two days were compared among 139 patients with 310 lung tumors who underwent 208 cryoablations (129 HFJV and 79 SR). The researchers found that the rates were greater for HFJV versus SR for treatment of multiple tumors per session (43 versus 19 percent) and nonperipheral tumor location (48 versus 24 percent). The major adverse event rate did not differ significantly between the groups (8 versus 5 percent). There were no occurrences of systemic air embolism. HLOS of at least two days occurred in 17 percent of sessions, with no significant difference noted for HFJV versus SR. No significant difference was seen in procedure time, CT guidance acquisition time, CT guidance radiation dose, or total radiation dose between ventilation modalities. Longer room time was seen for HFJV versus SR (154 versus 127 minutes). "The choice of ventilation modality in percutaneous lung ablation should be based on patient characteristics and anticipated procedural requirements, as well as operator preference," the authors write. One author disclosed ties to Pfizer and Boston Scientific. Abstract/Full Text (subscription or payment may be required) Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Eitan Medical is in the process of rolling out a new software update to correct the issue, which is present only in one now-discontinued version of the Sapphire infusion pumps’ software. The update is expected to be available within the next few months. Drug delivery devices are in the safety regulation crosshairs as of late, as a growing list of the technologies have found themselves the subject of recalls and corrections in recent weeks. Latest to join that list are infusion pumps from Eitan Medical, according to an FDA notice posted Friday. Like other infusion pumps, the recalled devices are used to deliver medications, blood, nutrients and other fluids to patients through an IV. They can be used either portably or in clinical and at-home settings, and they can run on either battery power or while plugged into an outlet. Israeli medtech Eitan began the recall in September, after becoming aware of an issue in a version of the pumps’ software. According to the FDA notice—which gave the recall the agency’s most serious rating, Class I—the software error could lead the pumps to fail to detect the presence of air in the IV line; if air is administered into a patient’s bloodstream, it could create a blood vessel-blocking embolism, leading to unstable blood pressure, stroke, heart attack or even death. The issue is specifically confined to cases where the pumps are running on battery power, per the notice, and Eitan has yet to receive any reports of injury or death associated with the software error. The recall spans the Sapphire MT, Sapphire Epidural and Sapphire Plus infusion pumps, nearly 1,400 of which have been distributed in the U.S. In a letter sent to clinical users of the devices, Eitan asked that they immediately stop using the affected pumps on battery power and instead keep them connected to continuous AC power or another power supply. Users should also add an air-eliminating filter to the device to help catch any missed instances of air embolisms. In the meantime, the company is in the process of rolling out a new software update to correct the issue, which is present only in the now-discontinued version Rev 16.10 of the pumps’ software. The update is expected to be available within the next few months. That Class I recall follows several others handed down to infusion pumps in the last few weeks. Baxter’s Novum IQ syringe pumps, for example, were found to contain a software defect that could cause them in certain circumstances to miscalculate the remaining volume of fluid to be delivered, determining that an infusion is complete before all fluid has been administered and therefore leading to underdosing of potentially life-sustaining medications. B. Braun Medical, meanwhile, earned its own Class I tag from the FDA for its Infusomat Space volumetric infusion pump system, for an issue that’s the opposite of Eitan’s: The large-volume pumps were found to potentially sound alarms for occlusions that haven’t actually occurred, automatically stopping all functions and therefore preventing patients from receiving the medications and other fluids they need. Rounding out the “B”-name trifecta, BD recently received a Class I label for an issue that has less to do with its Alaris infusion pumps and more to do with Cardinal Health’s Monoject syringes, which are currently facing a serious recall of their own. As Cardinal and the FDA continue to warn the public not to use millions of the syringes after their dimensions recently changed, BD issued a safety notice doubling down on the warning, reminding its own customers not to use the Cardinal-branded Monoject syringes with its Alaris pumps.