Merit Medical Systems (Nasdaq:MMSI) announced that its application for reimbursement for its Wrapsody procedures requires further CMS consideration. As a result, the company plans to go ahead with the U.S. rollout for the cell-impermeable endoprosthesis (CIE). "We have elected to withdraw our application for TPT incremental payment and intend … [Read more...] about Merit Medical to launch Wrapsody endoprosthesis in U.S. after CMS defers reimbursement decision
Boston Scientific, Siemens Healthineers ink 4D ICE catheter development deal
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] today announced a catheter development and commercialization deal with Siemens Healthineers. The deal centers around the workflow development and commercialization of Siemens Healthineers' AcuNav 4D intracardiac echocardiography (ICE) catheter. AcuNav 4D ICE technology is … [Read more...] about Boston Scientific, Siemens Healthineers ink 4D ICE catheter development deal
Boston Scientific enrolls first patient in AFib mapping study using OptiMap, Farapulse
A Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] official announced the enrollment of the first patients in the OPTIMIZE randomized controlled clinical trial. On LinkedIn, Nick Spadea-Anello, the company’s president of Electrophysiology, announced the enrollment in the trial. He said Dr. Oussama Wazni, global principal … [Read more...] about Boston Scientific enrolls first patient in AFib mapping study using OptiMap, Farapulse
CardioFocus enrolls first patients in PFA trial as it seeks European approval
CardioFocus announced today that it initiated clinical trials for its next-generation pulsed field ablation (PFA) technologies. The company kicked off its CE mark pivotal trial for the QuickShot Nav large-area focal PFA catheter and its next-generation CardioWave PFA system. Dr. Ante Anić leads the study, which enrolled the first patients at KBC … [Read more...] about CardioFocus enrolls first patients in PFA trial as it seeks European approval
Galvanize reports promising early results for pulsed electric field ablation for oncology
Galvanize Therapeutics today announced the publication of positive six-month results from its AFFINITY clinical trial in the medical journal Cancers. AFFINITY, a prospective, non-randomized, open-label, single-arm study evaluates the safety and feasibility of the company's Aliya platform. Aliya, a pulsed electric field (PEF) system, could … [Read more...] about Galvanize reports promising early results for pulsed electric field ablation for oncology
AVS reports positive results for pulsatile IVL tech
Amplitude Vascular Systems (AVS) today announced findings from the first 95 patients treated in its POWER PAD II U.S. pivotal study. POWER PAD II evaluates the company's pulsatile intravascular lithotripsy (PIVL) therapy. It assesses the safety and efficacy of the Pulse IVL system for treating moderate-to-severely calcified peripheral arterial … [Read more...] about AVS reports positive results for pulsatile IVL tech
J&J’s Shockwave shares data supporting Javelin forward IVL
Johnson & Johnson MedTech‘s Shockwave Medical today announced one-year results in a study using its Javelin peripheral IVL catheter. Yesterday, the company shared findings from a separate intravascular lithotripsy (IVL) study. It presented findings at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Today, it shared … [Read more...] about J&J’s Shockwave shares data supporting Javelin forward IVL
BD completes enrollment in vascular covered stent study
BD (NYSE: BDX) today announced that it completed enrollment in the iliac artery patient cohort in its pivotal AGILITY study. AGILITY, an FDA investigational device exemption (IDE) study, evaluates the Revello vascular covered stent in patients with peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD initiated the trial earlier … [Read more...] about BD completes enrollment in vascular covered stent study
Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes
Aqua Medical has received an investigational device exemption (IDE) from the FDA for its ablation device intended to treat diabetes, the company told MassDevice ahead of an official announcement later today. The IDE gives the device developer the green light to conduct a pilot clinical trial of its Proximal Intestinal Mucosal Ablation (PIMA) … [Read more...] about Aqua Medical wins FDA IDE to launch trial for ablation procedure that treats diabetes
More data supports Penumbra mechanical thrombectomy system
Penumbra (NYSE:PEN) announced additional results from its STORM-PE trial of computer-assisted vacuum thrombectomy (CAVT). The data release follows STORM-PE findings shared last week supporting the use of the company's Lightning Flash system at TCT 2025. Investigators shared additional results at this week's Vascular Interventional Advances (VIVA) … [Read more...] about More data supports Penumbra mechanical thrombectomy system
