Boston Scientific announced recently that it received CE mark for its Farapoint pulsed field ablation (PFA) catheter. The regulatory nod, earned last week, allows the Marlborough, Massachusetts-based company to bring the newest PFA catheter in its electrophysiology portfolio to the European market. Farapoint treats right atrial flutter (AFL), … [Read more...] about Boston Scientific gets European nod for Farapoint catheter
Cardiology
Atraverse wins FDA clearance for left heart access device
Atraverse Medical announced today that it received FDA clearance for its fully integrated Hotwire transseptal access system. Hotwire is a novel radiofrequency guidewire left-heart access device. It enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, a pioneer in the pulsed field … [Read more...] about Atraverse wins FDA clearance for left heart access device
Procyrion adds former Silk Road Medical exec as new CCO
Procyrion announced today that it appointed Andrew Davis as its new chief commercial officer (CCO), effective immediately. Houston-based Procyrion develops a catheter-deployed percutaneous mechanical circulatory support (pMCS) device called Aortix. The company designed the device to treat patients with acute decompensated heart failure (ADHF) … [Read more...] about Procyrion adds former Silk Road Medical exec as new CCO
CMS adds reimbursement for cardiac ablation in ASCs
The Centers for Medicare and Medicaid Services (CMS) has provided a major reimbursement update for cardiac ablation technologies. In its 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule, CMS added cardiac catheter ablation procedures to its ASC-covered procedures list. This … [Read more...] about CMS adds reimbursement for cardiac ablation in ASCs
VenstraMedical picks up investment for ventricular assist device
VenstraMedical announced today that it secured an investment to accelerate the development of its percutaneous ventricular assist device (pVAD). Highcroft Capital, a Minnesota-based venture capital firm specializing in medtech innovation, delivered the undisclosed investment. It supports the Newcastle, Australia-based company’s low-profile, … [Read more...] about VenstraMedical picks up investment for ventricular assist device
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
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
