Author: Ken Dropiewski

CorVista Health Appoints Nikki Troiano Gainey as Chief Customer Officer and Names Ian Shadforth Chief Strategy Officer

BETHESDA, Md.–(BUSINESS WIRE)–CorVista Health today announced the appointment of Nikki Troiano Gainey as Chief Customer Officer. In this role, Gainey will lead CorVista’s customer strategy, commercial execution, and market development, as the company expands adoption of the CorVista System, a non-invasive, point-of-care platform designed to support cardiovascular disease detection and clinical decision-making. As part of the leadership transition, Ian Shadforth has been appointed to the role

Amplifi Vascular Announces Major Clinical Milestone by Launching the AMPLIFI-1 Pivotal Trial to Expand Forearm Fistula Options for Hemodialysis Patients

Study evaluates whether Amplifi therapy enables AVF maturation at two weeks, potentially reducing catheter dependence and transforming the dialysis access pathway BOSTON, May 19, 2026 /PRNewswire/ — Amplifi Vascular, a clinical-stage medical technology company developing the Amplifi™…

Endologix Acquires Pounce™ Thrombectomy System, Expanding Its Vascular Intervention Portfolio

SANTA ROSA, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company focused on advancing innovative therapies for the interventional treatment of vascular disease, today announced the acquisition of the Pounce™ Thrombectomy System from Surmodics, Inc. The transaction closed on May 18, 2026. The Pounce System is an FDA-cleared, fully mechanical thrombectomy system for the non-surgical removal of thrombi and emboli from peripheral arteries. Built around proprietary

Merit Medical Shareholders Elect Scott R. Ward to Board of Directors

SOUTH JORDAN, Utah, May 19, 2026 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced that shareholders elected Scott R. Ward to the company’s Board of Directors at Merit’s annual meeting of shareholders. Mr. Ward was elected to serve a three-year term. “On behalf of the Board, we are pleased with Scott Ward’s election to Merit’s Board of Directors,” said F. Ann Millner, Merit’s Chair of the Board. “Scott’s extensive industry experience, strategic insight, and commitment to innovation will be tremendous assets as we continue advancing the company’s strategic priorities.” “We are proud to welcome Scott Ward to Merit’s Board,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “Scott brings deep medical device experience and a proven leadership track record. As we continue building on our foundation and advancing our strategy, his perspective will be invaluable to our long-term growth.” “I am honored to join the Merit Board of Directors,” Ward said. “I have great respect for Merit’s commitment to innovation and its focus on serving patients and healthcare providers around the world. I look forward to contributing my experience as the company continues to grow and expand its impact.” Mr. Ward brings more than 40 years of experience in the healthcare and medical device industry, including nearly three decades at Medtronic, where he held senior leadership roles such as senior vice president and president of the cardiovascular, neurological, and diabetes businesses. He most recently served as CEO, President and Chairman of Cardiovascular Systems, Inc., leading the company through a period of expansion and its acquisition by Abbott. Mr. Ward is also the founder of Raymond Holdings, a firm focused on venture capital, strategy, and advisory services for medical technology and life sciences companies, and has served on numerous public and private company boards. Merit’s Board of Directors has appointed Mr. Ward to serve on its Governance and Sustainability and Finance and Operating Committees. ABOUT MERIT MEDICAL Founded in 1987, Merit is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,600 people worldwide. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTSMedia InquiriesSarah Comstock Merit Medical+1-801-432-2864 | sarah.comstock@merit.com Investor InquiriesMike Piccinino, CFA, IRC ICR Healthcare+1-443-213-0509 | mike.piccinino@icrhealthcare.com

EuroPCR 2026: Elixir Medical’s DynamX® Bioadaptor Demonstrates Significantly Lower Event Rates Than Drug-Eluting Stent

EuroPCR 2026: Elixir Medical’s DynamX® Bioadaptor Demonstrates Significantly Lower Event Rates Than Drug-Eluting Stent in Long-Term Follow-Up, Including Reduction in Cardiovascular DeathParis, France, May 19, 2026 (GLOBE NEWSWIRE) — Significantly lower TLF rates (2.8% versus 7.8%, p=0.020) with DynamX® compared to Resolute Onyx DES with no new events in bioadaptor arm between 3 and 4 years 88% reduction in Cardiovascular Death (0.5% versus 3.7%, p=0.020) with DynamX® compared to DES PARIS – May 19, 2026 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced four-year results from the large 445-patient BIOADAPTOR Randomized Controlled Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute Onyx™ Drug-Eluting Stent (DES) at 34 centers in Japan, Europe, and New Zealand. The data were presented at a late-breaking clinical trial session during the EuroPCR 2026 conference in Paris. “Interventional cardiologists typically use a drug-eluting stent (DES) during percutaneous coronary intervention (PCI) to open the heart blockage and keep the artery open. These interlocked mesh-like tubes, however, permanently cage the artery, limiting its function and contributing to an annual 2-3% increase in adverse clinical events over time,” – said Professor Stefan Verheye, M.D., Ph.D., interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium and leading DynamX® investigator. “The bioadaptor is a new type of unlocking, adaptive implant designed to keep the artery open while restoring normal vessel function, its compliance and pulsatility.” Late-breaking four-year results presented at EuroPCR highlight durable clinical outcomes with the DynamX® bioadaptor, with no new target lesion failure (TLF) or cardiovascular death (CVD) events observed between years three and four, maintaining a very low plateauing rate of adverse events compared to the continued annual increase seen with DES. DynamX® demonstrated a 66% lower TLF rate (2.8% versus 7.8%; p=0.020) compared to DES, reflecting significant clinical benefit and long-term durability of PCI treatment with bioadaptor. The TLF reduction was driven by improvement across all components of the device-related combined endpoint, including: 88% lower cardiovascular death (0.5% versus 3.7%, p=0.020), a statistically significant reductionNumerically lower target vessel myocardial infarction (0.9% versus 1.8%)Numerically lower clinically driven target lesion revascularization (1.4% versus 2.8%) These findings highlight a key differentiation of the bioadaptor implant from drug-eluting stents: while DES outcomes continue to accrue adverse events over time, DynamX® demonstrates stabilization of event rates following restoration of vessel function at 6 months post-procedure. Substantial clinical improvement was also observed in the left anterior descending (LAD) artery, with TLF rates dramatically lower with DynamX® compared to DES (2.7% versus 10.6%; p=0.021), potentially reflecting an amplified impact of restoring vessel function in this hemodynamically critical coronary vessel responsible for about 50% of heart blood supply. “The DynamX® bioadaptor represents a significant advancement in PCI by providing functional restoration of the artery,” – remarked Shigeru Saito, M.D., trial principal investigator and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “Furthermore, the significant finding in reducing cardiovascular mortality marks a major achievement in how we treat cardiovascular disease and improve patient outcomes.” PCI procedures have been successful at improving the conductance of blood through diseased, blocked coronary arteries. Stents establish luminal diameter and improve the acute mechanical result of PCI compared to balloon angioplasty. However, DES do not restore the physiology of the vessel wall because they create rigid scaffolding. This constrains vessel elasticity and prevents return to a more normal, pulsatile function. The DynamX® bioadaptor first achieves the initial objective of opening the artery in establishing luminal diameter to improve blood flow. Unlike DES, it transitions to a different structure following an initial period of healing where it unlocks and provides the essential radial dynamic support to the diseased artery, allowing the treated segment to recover pulsatility and compliance. “The four-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT have shown consistently across multiple randomized clinical trials significantly lower, plateauing clinical events with DynamX® bioadaptor compared to DES treatment, demonstrating the clear benefit of restoring a key function of arteries, hemodynamic modulation, with this breakthrough technology.” – said Motasim Sirhan, CEO of Elixir Medical. About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial 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 part of Elixir Medical’s robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients. About DynamX® Sirolimus Eluting Coronary Bioadaptor SystemThe 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 from six months through four-year clinical follow-up.  The DynamX® Sirolimus Eluting Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device, limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir 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. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn. ### Media Contact:Richard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216

BioStar Capital-Backed Amplitude Vascular Systems’ $835M Acquisition by Stryker Reflects Strength of Michigan’s Medtech Ecosystem

CHARLEVOIX, Mich.–(BUSINESS WIRE)–BioStar Capital, a venture capital firm focused on transformative medical technologies, has announced a landmark pre-FDA exit of Amplitude Vascular Systems, Inc. (AVS), a medical technology company that created a next-generation hydraulic intravascular lithotripsy (IVL) platform to treat calcified peripheral arterial disease. Upon acquiring AVS for up to $835 million, Stryker (NYSE:SYK), a global leader in medical technologies, called the deal a milestone in

AVS, Now Part of Stryker, Enrolls First Patient in First-in-Human Coronary Intravascular Lithotripsy Study

BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company recently acquired by Stryker and focused on treating severely calcified arterial disease, today announced the enrollment of the first patient in its first-in-human (FIH) study for Pulsatile Intravascular Lithotripsy (PIVL) therapy in a coronary indication. The POWER CAD I study will evaluate the feasibility of the Pulse IVL™ System for the treatment of patients with moderate to severely calcified coronary arteri