R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK pivotal trial for the next-generation bioresorbable scaffold. R3 Vascular makes […]
Cardiovascular
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical Program […]
CorFlow Therapeutics raises $48.5M for diagnostic, drug delivery platform
CorFlow Therapeutics announced today that it raised €44 million ($48.5 million) to support its novel diagnostic and drug delivery platform. Broadview Ventures and Panakes Partners led the financing round. 415 Capital, Merieux Equity Partners, Merieux Equity Partners, Laerdal Million Lives Fund, Wellington Partners, M&L Investments, Unorthodox Ventures, KOFA Healthcare and Monte Carlo Capital also participated. […]
Elutia announces first implant of drug-eluting bioenvelope for pacemakers and neurostimulators
Elutia (Nasdaq:ELUT) announced the first-ever patient implant of its EluPro drug-eluting biologic envelope cleared by the FDA. Dr. John Catanzaro of the East Carolina University Health Medical Center in Greenville, North Carolina, performed the first procedure. Elutia says this marks the first implant of the world’s first antibiotic-eluting biologic envelope. Elutia designed EluPro to prevent […]
Reflow Medical enrolls first patient in coronary sirolimus-eluting retrievable scaffold system study
Reflow Medical announced that investigators enrolled the first patients in a trial of its Spur sirolimus-eluting retrievable scaffold system. DEEPER CORONARY evaluates the Spur Elute stent as a primary treatment for in-stent restenosis (ISR) of the coronary arteries. Spur Elute offers a treatment by transferring a proprietary drug formulation to the diseased lesion without leaving […]
Cordis reports positive 2-year data for drug-eluting balloon
Cordis today announced positive 24-month results from a study evaluating its Selution SLR drug-eluting balloon (DEB). Selution SLR offers endovascular therapy for de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). Cordis acquired the DEB technology from MedAlliance for $1.135 billion last fall. The company presented data […]
Elixir Medical wins FDA breakthrough nod for sirolimus-eluting bioadaptor system
Elixir Medical announced today that it received FDA breakthrough device designation for its DynamX bioadaptive implant. The breakthrough nod covers the improvement of coronary luminal diameter, restoration of hemodynamic modulation and reduction of plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. It follows a March […]
Surmodics to be acquired by private equity firm for $627M
Surmodics (Nasdaq:SRDX) announced today that it agreed to be acquired by GTCR, a private equity firm with healthcare interests. Eden Prairie, Minnesota-based Surmodics develops a range of technologies, including drug-coated balloons and thrombectomy systems. Its SurVeil DCB received a long-awaited FDA approval in June 2023. The company also reported successful early clinical use of its […]
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott [WtwhTicker symbol=”ABT”](NYSE: ABT)[/WtwhTicker] announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. According to a news release, no stents or drug-coated […]
Concept Medical enrolls first patient in drug-coated balloon study
Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
