Agency’s Breakthrough Device Designation Program Allows for Priority Review of Ablation Technology for Ventricular Tachycardia LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that it has received Breakthrough Device designation […]
Rhythm
LUMA Vision Receives FDA Clearance for VERAFEYE 2D/4D Cardiac Visualization Platform
Real-Time, 360-Degree Imaging Enhances Precision and Confidence in Cardiac Procedures DUBLIN, April 16, 2025 /PRNewswire/ — LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, today announced the FDA clearance of its VERAFEYE™ Visualization Platform. This…
Catheter Precision, Inc. Receives Notice of First Patent Allowance in the US for LockeT Product Line
Fort Mill, S.C., April 14, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that it has received a notice of allowance from the US Patent Office of its first patent in the US for its LockeT product, filed in December 2022, for its design of a surgical closure device for orthoscopic entry wounds.
Merit Medical Launches the Ventrax™ Delivery System
Novel all-in-one retrograde aortic access delivery system supports streamlined treatment of ventricular tachycardiaSOUTH JORDAN, Utah, April 09, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader in healthcare technology, today announced the US commercial release of its Ventrax Delivery System. The new delivery system is Merit’s latest addition to its growing electrophysiology (EP) and cardiac rhythm management (CRM) portfolio. The portfolio provides a unique selection of solutions to improve cardiac interventions, including the HeartSpan®, Worley™, Prelude SNAP™, and SafeGuard Focus® product lines. Ventrax is intended to facilitate placement of devices used in ablation procedures commonly performed to treat an abnormally fast heartbeat known as ventricular tachycardia (VT). Ventricular arrhythmias, which include VT, are believed to cause approximately three out of four sudden cardiac deaths, which result in an estimated 184,000–450,000 lives lost in the United States each year.¹ The all-in-one device provides a streamlined pathway for ablation catheters to enter the left ventricle through the aorta, an approach known as retrograde aortic access. “For the electrophysiologist, using retrograde aortic access was always a risk-benefit decision, and the community has needed a tool that would make that decision easier,” said Albert Sun, MD, electrophysiologist at Duke Health in Durham, NC, and whose advice was instrumental in Merit’s development of the Ventrax system. Retrograde aortic access can be useful to reach certain areas of the ventricle compared to traditional methods, such as transseptal puncture. Using this approach, these areas of the left ventricle are more accessible,² supporting targeted treatment. “The new retrograde delivery system provides access to the left ventricle, allowing for the exchange of catheters to diagnose, map, or treat VT,” said Jason Koontz, MD, PhD, electrophysiologist at Duke Health and product development consultant to Merit. “This adds to our tools as we work to deliver the best possible outcomes for our patients.” Learn more about the Ventrax Delivery System Key features of the Ventrax Delivery System include a 95-cm sheath designed to access desired target locations. An ultralow-profile transition between its sheath and pigtail-dilator offers smooth insertion, and an angled tip enhances the reach of an ablation catheter. VT ablation is one of the fastest growing areas in electrophysiology. Many physicians are using retrograde aortic access for VT procedures, and researchers are increasingly investigating the technique. “Effective access is essential to supporting the growth of VT ablation,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are proud to take another significant step toward providing electrophysiologists with a valuable tool that helps fill this need in patient care.” ABOUT MERIT MEDICAL Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,000 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. CONTACTSPR/Media InquiriesSarah ComstockMerit Medical+1-801-432-2864 | sarah.comstock@merit.com INVESTOR INQUIRIESMike Piccinino, CFA, IRCWestwicke – ICR+1-443-213-0509 | mike.piccinino@westwicke.com Khurshid et al. 2018. “Frequency of Cardiac Rhythm Abnormalities in a Half Million Adults.” Circ Arrhythm Electrophysiol 11 (7): e006273. (PMID: 29954742)Adlan et al. 2019. “Retrograde Aortic Access During Ventricular Tachycardia Ablation: Indications, Techniques, and Challenges.” Journal of Cardiovascular Electrophysiology 30 (11): 2629–2639. (PMID: 31502368)
Elutia to Debut EluPro™ at HRS 2025 — Experience the Difference Biology Makes
Introduction of EluPro at Heart Rhythm 2025 in San Diego, April 25-27, 2025 SILVER SPRING, Md., April 02, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, is proud to announce the debut of its EluPro™ Antibiotic-Eluting BioEnvelope designed for cardiac implantable electronic devices (CIEDs) and neurostimulators at the Heart Rhythm Society’s annual meeting (HRS 2025). Attendees will have the opportunity to experience firsthand the soft, conforming feel of EluPro and discover how its natural biomatrix supports healing while delivering trusted antibiotics to reduce bacterial colonization. Engineered for both performance and handling, EluPro features a proprietary biomatrix that drapes naturally around CIEDs, avoiding the rough, stiff feel often associated with synthetic alternatives. Combined with a trusted dual-antibiotic combination, EluPro offers physicians a solution designed for both efficacy and ease of use without compromise. “We are thrilled to introduce EluPro at HRS 2025 and give clinicians the opportunity to feel the difference biology makes,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “With its soft, conforming biomatrix and proven antibiotics, EluPro represents a meaningful step forward in CIED antibiotic envelope technology.” Elutia invites physicians and medical professionals to experience EluPro firsthand at booth #2418 at the San Diego Convention Center from April 25-27, 2025. Attendees interested in scheduling a meeting with Elutia during the conference may register through the HRS 2025 meeting portal here or contact ir@elutia.com. Those unable to attend can contact Elutia to speak with a representative and learn more about how EluPro is redefining CIED protection. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Forward-looking statements contained in this press release include, without limitation, any statements we make regarding the potential for EluPro to represent a meaningful step forward in CIED antibiotic envelope technology. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: the risk that clinical research data may not match preclinical study data; our ability to successfully commercialize, market and sell our EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
The FARAPULSE™ Pulsed Field Ablation System Demonstrates Superior Efficacy in Patients Treated for Paroxysmal Atrial Fibrillation
New findings from the SINGLE SHOT CHAMPION trial (NCT05534581), presented at EHRA 2025 and published in the New England Journal of Medicine, showed the FARAPULSE™ Pulsed Field Ablation (PFA) System to be superior in reducing atrial arrhythmia (AA) recurrence for treating symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF) compared to the Artic Front Advance™ cardiac cryoablation catheter. […]
Elutia Announces GPO Agreement with Advantus Health Partners to Expand Access to EluPro™
Seventh GPO Agreement Signed Since EluPro’s Launch SILVER SPRING, Md., March 27, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, announced that it has entered into an agreement with Advantus Health Partners (“Advantus”), to provide access of Elutia’s EluPro™ Antibiotic Eluting BioEnvelope to Advantus’ core group purchasing organizations (GPO) solutions portfolio. “Teaming up with Advantus is another major step forward in meeting the strong customer demand for EluPro,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “Our pilot launch of EluPro has exceeded our expectations as physicians recognize the unique value that this antibiotic envelope brings in preventing infection for patients that use a cardiac implantable electronic device. Broadening our GPO coverage with Advantus allows us to benefit from their sustainable contracting solutions, making EluPro more widely available to physicians nationwide.” EluPro is the world’s first and only antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration for use with cardiac implantable electronic devices (CIEDs) and neurostimulators. Combining powerful antibiotics with a natural extracellular matrix that regenerates into the patient’s own tissue, EluPro addresses critical post-surgical challenges, including infection, migration, and skin erosion, offering a transformative solution for both patients and clinicians. With the addition of Advantus, Elutia has now secured agreements with seven major national group purchasing organizations. Advantus Health Partners is a health care solutions company that makes supply chain easier for its clients through streamlined supply chain management, organizational purchasing, operations and cost-savings efficiencies. With innovation at the forefront, and an advanced operational model, Advantus provides a portfolio of solutions to further drive value beyond contracting, all with the singular goal of reducing health care costs across the U.S. Advantus is committed to helping organizations meet business goals through its distinct solutions. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the launch and market reception of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our newly approved EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms
Abbott’s Volt™ PFA System is designed to provide a new therapy option for people battling heart rhythm disorders such as atrial fibrillation Pulsed field ablation – or PFA – uses high energy electrical pulses for ablation procedures that may offer benefits to targeting and treating tissue…
Four New Studies Demonstrate that Viz.ai Finds New Patients with Hypertrophic Cardiomyopathy Earlier When Embedded into the Clinical Workflow
SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data demonstrating how the Viz HCM module enables faster, accurate detection of signs of hypertrophic cardiomyopathy (HCM) to help ensure that more patients receive the care they need. Four studies, which will be […]
Coro Medical and Simon’s Heart Expand Access to Lifesaving AEDs Through Project AED365
Twenty AEDs donated to communities across the country to protect young hearts from sudden cardiac arrest FRANKLIN, Tenn., March 25, 2025 /PRNewswire/ — Coro Medical, a leader in life-saving medical devices, is proud to announce a new partnership with Simon’s Heart as part of its…



