Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear - Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month Clear

Start Date10 Dec 2018

Sponsor / Collaborator

Medtronic Japan Co. Ltd.

KCT0003082 / RecruitingPhase 4IIT

Comparison of Clinical outcomes between angio-guided spot stenting and angio-guided entire stenting using Zotarolimus eluting stent with the patients with diffuse long coronary lesions.

Start Date30 Sep 2016

Sponsor / Collaborator-

JPRN-UMIN000020421 / CompletedNot ApplicableIIT

Comparison of Chronic Intra-stent Condition after Resolute Zotarolimus-Eluting Stent Implantation with Dual versus Single Antiplatelet Therapy with Prasgrel - Dual versus Single Antiplatelet Therapy with Prasgrel for R-ZES implantation

Start Date01 Oct 2015

Sponsor / Collaborator-

100 Clinical Results associated with Zotarolimus

100 Translational Medicine associated with Zotarolimus

100 Patents (Medical) associated with Zotarolimus

757

Literatures (Medical) associated with Zotarolimus

01 Dec 2024·International Immunopharmacology

Zotarolimus alleviates post-trabeculectomy fibrosis via dual functions of anti-inflammation and regulating AMPK/mTOR axis

Article

Author: Chen, Guochun ; Chen, Huihui ; Zhao, Cong ; Liu, Jingyuan ; Chen, Gong ; Wang, Zhiruo ; Shi, Jingming ; Li, Haoyu ; Yang, Yuanyuan ; Li, Yunping

OBJECTIVEPostoperative scar formation is the primary cause of uncontrolled intraocular pressure following trabeculectomy failure. This study aimed to evaluate the efficacy of zotarolimus as an adjuvant anti-scarring agent in the experimental trabeculectomy.METHODSWe performed differential gene and Gene Ontology enrichment analysis on rabbit follicular transcriptome sequencing data (GSE156781). New Zealand white Rabbits were randomly assigned into three groups: Surgery only, Surgery with mitomycin-C treatment, Surgery with zotarolimus treatment. Rabbits were euthanized 3 days or 28 days post-trabeculectomy. Pathological sections were analyzed using immunohistochemistry, immunofluorescence, and Masson staining. In vitro, primary human tenon's capsule fibroblasts (HTFs) were stimulated by transforming growth factor-β1 (TGF-β1) and treated with either mitomycin-C or zotarolimus. Cell proliferation and migration were evaluated using cell counting kit-8, cell cycle, and scratch assays. Mitochondrial membrane potential was detected with the JC-1 probe, and reactive oxygen species were detected using the DCFH-DA probe. RNA and protein expressions were quantified using RT-qPCR and immunofluorescence.RESULTSTranscriptome sequencing analysis revealed the involvement of complex immune factors and metabolic disorders in trabeculectomy outcomes. Zotarolimus effectively inhibited fibrosis, reduced proinflammatory factor release and immune cell infiltration, and improved the surgical outcomes of trabeculectomy. In TGF-β1-induced HTFs, zotarolimus reduced fibrosis, proliferation, and migration without cytotoxicity via the dual regulation of the TGF-β1/Smad2/3 and AMPK/AKT/mTOR pathways.CONCLUSIONOur study demonstrates that zotarolimus mitigates fibrosis by reducing immune infiltration and correcting metabolic imbalances, offering a potential treatment for improving trabeculectomy surgical outcomes.

01 Nov 2024·The Lancet

Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial

Article

Author: Erlinge, David ; Zwackman, Sammy ; Törnerud, Mattias ; Alström, Patrik ; Andersson, Jonas ; James, Stefan ; Böhm, Felix ; Hamid, Mehmet ; Abizaid, Andrea ; Grimfjärd, Per ; Smits, Pieter C ; Adielsson, Martin ; Held, Claes ; Wagner, Henrik ; Millgård, Jonas ; Ulvenstam, Anders ; Elek, Candace ; Fröbert, Ole ; Kellerth, Thomas ; Renlund, Henrik ; Jurga, Juliane ; Oldgren, Jonas ; Masoe, Elli ; Winnberg, Oscar

BACKGROUNDPersistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population.METHODSINFINITY-SWEDEHEART is a single-blind, non-inferiority, registry-based, randomised controlled study conducted in 20 hospitals in Sweden. Patients aged 18-85 years, with chronic or acute coronary syndrome ischaemic heart disease, with an indication for PCI, with up to three de novo lesions suitable for implantation with one single device per lesion, and successful pre-dilatation were identified via the Swedish Coronary Angiography and Angioplasty Registry and eligible for enrolment. Participants were randomly assigned (1:1), using block randomisation with random variation in block size and stratified by site, to either the DynamX bioadaptor (Elixir Medical, Milpitas, CA, USA) or a zotarolimus-eluting DES (Resolute Onyx and Onyx Trustar, Medtronic, Minneapolis, MN, USA). The primary endpoint was the device-oriented clinical endpoint of target lesion failure at 12 months (a composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target lesion revascularisation), assessed in the intention-to-treat (ITT) population (ie, all patients randomly assigned to treatment, regardless of treatment received) who had either experienced an event up to 12 months or completed the trial up to 12 months. Non-inferiority was established if the upper limit of the two-sided 95% CI for the absolute risk difference was less than 4·2%. Powered secondary endpoints were landmark analyses from 6 months onwards for target lesion failure, target vessel failure (composite of cardiovascular death, target vessel myocardial infarction, and ischaemia-driven target vessel revascularisation), and target lesion failure for patients with acute coronary syndrome assessed in the ITT population). This study is registered with ClinicalTrials.gov, NCT04562805, and follow-up to 5 years is ongoing.FINDINGSBetween Sept 30, 2020, and July 11, 2023, 2399 patients were randomly assigned to receive the bioadaptor (n=1201) or DES (n=1198; ITT population). Median age was 69·5 years (IQR 61·2-75·6), 575 (24·0%) of 2399 patients were female, and 1824 (76·0%) were male (data on race and ethnicity were not collected), and 1838 (76·6%) patients presented with acute coronary syndrome. The primary endpoint of 12-month target lesion failure occurred in 28 (2·4%) of 1189 assessable patients in the bioadaptor group versus 33 (2·8%) of 1192 assessable patients in the DES group, with a risk difference of -0·41% (95% CI -1·94 to 1·11; p_{non-inferiority}<0·0001). In the prespecified landmark analysis from 6 months to 12 months, the Kaplan-Meier estimates of target lesion failure were 0·3% (with events in three of 1170 patients) in the bioadaptor group versus 1·7% (with events in 16 of 1176 patients) in the DES group (hazard ratio 0·19 [95% CI 0·06 to 0·65]; p=0·0079), of target vessel failure were 0·8% (events in eight of 1167) versus 2·5% (events in 23 of 1174; 0·35 [0·16 to 0·79]; p=0·011), and of target lesion failure in patients with acute coronary syndrome were 0·3% (events in two of 906) versus 1·8% (events in 12 of 895; 0·17 [0·04 to 0·74]; p=0·018). The rate of definite or probable device thrombosis, which was recorded as a safety outcome, was low and did not differ between groups (eight [0·7%] of 1201 in the bioadaptor group vs six [0·5%] of 1198 in the DES group; difference in event rates of 0·16% [95% CI -0·50 to 0·83]).INTERPRETATIONAmong patients with coronary artery disease, including those with acute coronary syndrome, treatment with the bioadaptor was non-inferior to contemporary DES, showing potential to mitigate non-plateauing device-related events and improving outcomes in patients undergoing PCI. The additional planned follow-up will help to reinforce the clinical significance of the 1-year findings.FUNDINGElixir Medical.

01 Nov 2024·American Heart Journal

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent

Article

Author: Erlinge, David ; Elek, Candace ; Törnerud, Mattias ; Oldgren, Jonas ; Andersson, Jonas ; Held, Claes ; Fröbert, Ole ; Böhm, Felix ; Sirhan, Motasim ; James, Stefan

BACKGROUNDModern drug-eluting stents have seen significant improvements, yet still create a rigid cage within the coronary artery. There is a 2% to 4% annual incidence of target lesion failure (TLF) beyond 1 year, and half of the patients experience angina after 5 years. The DynamX bioadaptor is a sirolimus-eluting, thin (71 µm) cobalt-chromium platform with helical strands that unlock and separate after in vivo degradation of the bioresorbable polymer coating. This allows the vessel to return to normal physiological function and motion, along with compensatory adaptive remodeling, which may reduce the need for reintervention and alleviate angina following percutaneous coronary intervention (PCI).METHODSThe INFINITY-SWEDEHEART trial is a single-blind, registry-based randomized clinical trial (R-RCT) to evaluate the safety and effectiveness of the DynamX bioadaptor compared to the Resolute Onyx stent in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions. The R-RCT framework allows for recruitment, randomization, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries integrated with the trial database. The primary objective is to demonstrate noninferiority in terms of freedom from TLF (cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year. Powered secondary endpoints will be tested sequentially for superiority from 6 months to the end of follow-up (5 years) for the following: 1) TLF in all subjects, 2) target vessel failure in all subjects, and 3) TLF in subjects with acute coronary syndrome (ACS). Subsequent superiority testing will be performed at a time determined depending on the number of events, ensuring sufficient statistical power. Change in angina-related symptoms, function and quality of life will be assessed using the Seattle Angina Questionnaire-short version. Predefined sub-groups will be analyzed. In total, 2400 patients have been randomized at 20 sites in Sweden. Available baseline characteristic reveal relatively old age (68 years) and a large proportion of ACS patients including 25% STEMI and 37% NSTEMI patients.SUMMARYThe INFINITY-SWEDEHEART study is designed to evaluate the long-term safety and efficacy of the DynamX bioadaptor compared to the Resolute Onyx stent in a general PCI patient population.

News (Medical) associated with Zotarolimus

02 Sep 2024

·www.businesswire.com

ESC Congress 2024: INFINITY-SWEDEHEART Trial of Elixir Medical’s DynamX Bioadaptor Meets Primary Endpoint and Clinical Results Confirm Unique Mechanism of Action

LONDON--( BUSINESS WIRE )-- Elixir Medical , a developer of disruptive technologies to treat cardiovascular disease, today announced the INFINITY-SWEDEHEART Randomized Controlled Trial (RCT) comparing the novel DynamX ® Coronary Bioadaptor System with the contemporary Resolute Onyx ™ zotarolimus drug-eluting stent (DES) met its primary endpoint of target lesion failure (TLF) non-inferiority (2.35% versus 2.77%; p<0.001) at 12 months. The data were presented as a late-breaking Hot Line session at the European Society of Cardiology (ESC) Congress 2024 in London. “ The DynamX bioadaptor represents a significant clinical advancement in the treatment of coronary artery disease with a unique mechanism of action six months following the percutaneous coronary intervention (PCI) procedure,” said principal investigator David Erlinge, M.D., Ph.D., and head of the Cardiology Department at Lund University, Lund, Sweden. “ Each year millions of patients undergo PCI globally, and while a very safe procedure, the implantation of stents has been associated with an annual recurring adverse event rate. Sustained reduction and plateauing of these recurring adverse clinical events would create a major benefit over the lifetime of a patient.” Clinical results from the 2,400-patient INFINITY-SWEDEHEART study demonstrated: TLF of 2.35% versus 2.77% met non-inferiority (p<0.001) at 12 months for DynamX bioadaptor and Resolute Onyx DES, respectively. The low TLF with DynamX was driven by numerically low adverse events across components of the composite endpoint with DynamX compared to Resolute Onyx DES, respectively: Target vessel myocardial infarction (TV-MI) (1.27% versus 1.52%) Ischemia-driven target lesion revascularization (ID-TLR) (1.27% versus 2.11%) Cardiovascular death (0.59% versus 0.50%) Target vessel failure (TVF) at 12 months was also lower at 3.03% versus 3.52%, for DynamX compared to DES, respectively. Landmark analysis 1 : Pre-specified landmark analyses of TLF and TVF after six months demonstrated: Statistically significant reduction in TLF with DynamX (0.2% versus 1.3%, p=0.003) Statistically significant reduction in TVF with DynamX (0.6% versus 1.8%, p=0.008) These event rates were driven by reduction across all components of these composite endpoints “ The results of our trial strongly support the clinical impact of the Bioadaptor in coronary artery disease treatment, with a potential to significantly reduce the recurring adverse event risk after percutaneous coronary intervention in a population representative of everyday clinical practice,” said study chair Stefan James, M.D., Ph.D., and Professor of Cardiology at Uppsala University, Sweden. “ The Bioadaptor technology has proven to be able to do this through its unique design and mechanism of action of restoring hemodynamic modulation of a diseased artery. The DynamX bioadaptor was recently granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The bioadaptor has a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore more normal vessel biology. Locked phase: The bioadaptor establishes maximum flow lumen to restore blood flow. Unlocked/Separation phase: Unique to the bioadaptor, after six months, helical strands unlock and separate to allow adaptive remodeling of the vessel to maintain the established blood flow lumen. Adaptive dynamic support phase: The three—now independent—helical strands continue to provide essential support as the bioadaptor re-establishes vessel hemodynamic modulation through restoration of pulsatility, compliance and adaptive blood flow volume. “ Results from the INFINITY-SWEDEHEART trial validate in a broad, more clinically complex patient population what we’ve shown previously in BIOADAPTOR RCT and several mechanistic and investigator-initiated studies – consistency of low and plateauing adverse event rates after the unlocking of the bioadaptor at six months,” said Motasim Sirhan, CEO of Elixir Medical. “ We are thrilled by the results from the landmark analysis data after six months showing statistically significant reduction in TLF and TVF versus DES. As an innovation-driven company, these data further validate the bioadaptor’s unique mechanism of action and its advantage in treating coronary artery disease to improve the standard of care for our patients.” About the INFINITY-SWEDEHEART Trial The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is executed in partnership with the ongoing SWEDEHEART registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for heart disease. Study management is conducted in collaboration with Uppsala Clinical Research Center (UCR), a non-profit organization providing clinical research services for the development and improvement of health care in Sweden and worldwide. DynamX Coronary Bioadaptor System The DynamX bioadaptor is designated by the FDA as a breakthrough technology and is the first coronary implant designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and to provide plaque stabilization and regression. With this unique mechanism of action (MOA), the bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds translating to remarkably low clinical event rates that plateau after six months as demonstrated in two randomized controlled trials, BIOADAPTOR-RCT (N=445) and INFINITY-SWEDEHEART (N=2,400). The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at www.elixirmedical.com and on LinkedIn and X . Reference: 1 Erlinge, D., Andersson, J., Fröbert, O., Törnerud, M., Böhm, F., Held, C., Elek, C., Sirhan, M., Oldgren, J., & James, S. (2024). Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent. American Heart Journal, 277, 1-10. https://doi.org/10.1016/j.ahj.2024.07.016

Clinical ResultClinical StudyAHABreakthrough Therapy

13 Aug 2024

·www.businesswire.com

Elixir Medical to Present Late-Breaking One-Year Primary Outcomes from the 2,400 Patient INFINITY-SWEDEHEART Clinical Trial at ESC Congress 2024

MILPITAS, Calif.--( BUSINESS WIRE )-- Elixir Medical , a developer of disruptive technologies to treat cardiovascular disease, today announced it will present one-year clinical outcomes from the 2,400 patient INFINITY-SWEDEHEART Randomized Clinical Trial (RCT), a prospective, multi-center, single-blind, clinical trial comparing the drug-eluting DynamX Coronary Bioadaptor System with the contemporary Resolute Onyx TM zotarolimus drug-eluting stent (DES), at a late-breaking Hot Line session at ESC Congress 2024 in London. “Today’s minimally invasive coronary artery disease (CAD) treatments are limited to only establishing a fixed flow lumen in the artery which re-narrows over time presenting an unacceptable major adverse event rate (MACE) of 20% by five years 1 and up to 50% by 10 years 2 , increasing annually without a plateau 3 . The DynamX bioadaptor was developed to address and surpass the limitations of CAD treatments by not only being capable of establishing a flow lumen, but also uniquely restoring the essential attributes of vessel function to adapt and maintain the established flow lumen, restore hemodynamic modulation of the artery, and reduce plaque progression to deliver a sustained, low adverse event rate that plateaus after six months,” said Motasim Sirhan, CEO of Elixir Medical. “Building on the exceptional results of the BIOADAPTOR-RCT study, where we observed a statistically significant 65% reduction in clinical events in de novo lesions by two years compared to Resolute Onyx DES 4 , the INFINITY-SWEDEHEART RCT will provide evidence of the DynamX bioadaptor performance in a broader, real-world patient population, including a large cohort of patients with acute coronary syndrome (ACS).” The INFINITY-SWEDEHEART RCT enrolled 2,400 patients from 20 sites in Sweden. The trial is executed through the SWEDEHEART registry program in Sweden, a national collaborative research program supporting the evidence-based development of therapies for heart disease. Study management is conducted in collaboration with Uppsala Clinical Research Center (UCR), a non-profit organization providing clinical research services for the development and improvement of health care in Sweden and worldwide. The data will be presented by David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE, in the Hot Line session “INFINITY-SWEDEHEART - Percutaneous coronary intervention with a bioadaptor compared to a contemporary drug-eluting stent – one-year primary outcomes.” The presentation will also include a discussant review and panel discussion. Presentation details : HOT LINE 11 Title : “INFINITY-SWEDEHEART - Percutaneous coronary intervention with a bioadaptor compared to a contemporary drug eluting stent- one-year primary outcomes” Principal investigator : David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE. Date : Monday, September 2, 2024 Time : 13:45 - 14:45 BST Location : Main Auditorium About the INFINITY-SWEDEHEART Trial The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is executed in partnership with the ongoing SWEDEHEART registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for heart disease. DynamX Coronary Bioadaptor System The DynamX bioadaptor is designated by the U.S. Food and Drug Administration (FDA) as a breakthrough technology and is the first coronary implant designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and to provide plaque stabilization and regression. With this unique mechanism of action (MOA), bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds, translating to remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow-up in the BIOADAPTOR RCT study. The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S. About Elixir Medical Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at www.elixirmedical.com and on LinkedIn and X . References: 1. Iqbal et al. Final 5-Year Report of the RESOLUTE All-comers Trial. Circ Cardiovasc Interv. 2015. 2. Kufner et al. ISAR-TEST 4 Trial. Circulation, 2019. 3. Madhavan MV et al. J Am Coll Cardiol 2020;75:590-604 4. Saito S. Two-year clinical outcomes of the BIOADAPTOR RCT study. EuroPCR 2024.

Clinical StudyClinical ResultAHA

14 May 2024

·www.biospace.com

EuroPCR 2024: Late-Breaking Data Demonstrate Significant Clinical Advantage of Elixir Medical’s DynamX Bioadaptor Over Standard of Care Drug-Eluting Stent at Two Years

Statistically significant reduction in hard clinical endpoints of TLF and TVF with DynamX; event rate flattened after one year in bioadaptor versus non-plateauing increase in DES In Left Anterior Descending (LAD) artery, bioadaptor demonstrated statistically significant 78% reduction in target lesion failure versus DES PARIS--(BUSINESS WIRE)-- Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced two-year results from the BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results, for the first time, demonstrate significant reduction in adverse events and clinical advantage of the DynamX bioadaptor in target lesion failure (TLF) and secondary endpoint of target vessel failure (TVF) driven by sustained low event rates with DynamX compared to a two-fold increase in DES. The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference in Paris. Clinical results show statistically significant benefit with DynamX bioadaptor over Resolute Onyx at two years: 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046). The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX compared to DES, respectively: Cardiovascular death (0% versus 1.8%) Target vessel myocardial infarction (0.9% versus 1.9) Target lesion revascularization (0.9% versus 2.3%) 68% reduction in TVF rate (1.9% versus 6.0%; p=0.029) in DynamX compared to DES Two-year lesion subset results: 78% reduction (1.9% vs.8.7%; p=0.028) in TLF rate in left anterior descending (LAD) artery lesions treated with DynamX bioadaptor versus treatment with DES Small vessels (<2.75mm) TLF rate was 0% vs. 3.5% in DynamX versus DES, respectively Long lesions (>23mm) TLF rate was 0% vs. 2.3% in DynamX versus DES, respectively “These two-year results from the BIOADAPTOR RCT trial are very exciting—unlike anything we’ve ever seen before—and represent a new treatment category for patients living with coronary artery disease. The TLF rate curve separation validates how the bioadaptor’s unique design and mechanism of action restores the vessel viability, including the LAD vessel. It does this by restoring hemodynamic modulation validating the previously demonstrated superior imaging outcomes at one year. These data show that bioadaptor offers sustained, very low event rates across all major endpoints, making it a superior option compared to DES,” said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “The 78% magnitude of reduction in clinical events in LAD lesions is particularly important, as the artery provides 50% of a heart muscle’s blood supply and undergoes significant hemodynamic movement during every cardiac cycle. Restoring its function is clearly of significant benefit.” The DynamX bioadaptor is different from current standard of care therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. The locked phase establishes maximum flow lumen and restores blood flow. Unique to bioadaptor, the unlocked and separation phase of bioadaptor’s helical strands releases the vessel while maintaining the established blood flow lumen. The final phase provides adaptive dynamic support after the unlocking and separation phase to restore vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has shown evidence of plaque stabilization and regression in the lesion. “We are beyond thrilled with these findings from the BIOADAPTOR RCT,” said Motasim Sirhan, CEO of Elixir Medical. “Never before have we seen a vascular technology that addresses the limitations of existing revascularization therapies by restoring artery hemodynamic modulation and stabilizing or regressing plaque volume, as we have with DynamX bioadaptor. These exceptional patient clinical outcomes further validate that the bioadaptor is truly a transformative technology for coronary artery disease treatment.” About BIOADAPTOR RCT Trial The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial (RCT) comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor System The DynamX bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow up. The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S. About Elixir Medical Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn and X. View source version on businesswire.com: Contacts Emma Yang, Health+Commerce Email: emma@healthandcommerce.com Source: Elixir Medical View this news release online at:

Clinical ResultClinical StudyAHA

100 Deals associated with Zotarolimus

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KEGG	Wiki	ATC	Drug Bank
D06669	Zotarolimus	L04AA	-

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Approved

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Indication	Country/Location	Organization	Date
Coronary Restenosis	CA	AbbVie AS	16 May 2008

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Erectile Dysfunction	Phase 1	US	Medtronic Plc	-
Vascular restenosis	Phase 1	US	AbbVie AS	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SORT OUT VI (Pubmed \| JACC Cardiovasc Interv)	Not Applicable	Coronary Artery Disease	-	Durable-Polymer Zotarolimus-Eluting Stent	(fkuqswznpz) = sarfnltlyt mpfowtwujf (sthobscdvn ) View more	Positive	13 Feb 2017
				Biodegradable-Polymer Biolimus-Eluting Stent	(fkuqswznpz) = glolnwkfma mpfowtwujf (sthobscdvn ) View more
Pubmed \| J Am Coll Cardiol	Not Applicable	Coronary Artery Disease	-	Zotarolimus-eluting stent (ZES)	mcywhuzcvp(rgynudgdmo) = ngwdvzoinh ytetwahllh (hnzskqhdkt ) View more	-	03 Dec 2013
				Zotarolimus (Everolimus-eluting stent (EES))	mcywhuzcvp(rgynudgdmo) = hqjpajmsnu ytetwahllh (hnzskqhdkt ) View more
E-Five Registry (Pubmed \| Catheter Cardiovasc Interv)	Not Applicable	-	-	Endeavor zotarolimus-eluting stent	(yipbqorpth) = mxhtgueigj hexkpacsxx (afdlsxstad ) View more	-	01 Jun 2011
Pubmed \| JACC Cardiovasc Interv	Not Applicable	Coronary Artery Disease	401	Zotarolimus	juesyegddc(qcoyinrdmy) = ckpzgntroe upvzcdijyh (vhyambhdjg ) View more	Negative	01 Oct 2008
				Zotarolimus	juesyegddc(qcoyinrdmy) = rqmvtwkgmj upvzcdijyh (vhyambhdjg ) View more

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