Surmodics (Nasdaq:SRDX) announced today that it commercially launched the Pounce XL thrombectomy system for clot removal. Pounce XL joins the larger suite of Pounce thrombectomy systems. They offer rapid endovascular removal of acute or chronic clot from peripheral arteries. Eden Prairie, Minnesota-based Surmodics designed Pounce to enable … [Read more...] about Surmodics launches Pounce XL thrombectomy system
Boston Scientific Farapulse PFA system shows superiority in head-to-head study with Medtronic cryoablation system
Boston Scientific announced new study findings demonstrating the superiority of its Farapulse pulsed field ablation (PFA) system. Data published in the New England Journal of Medicine showed Farapulse's superiority in reducing atrial arrhythmia (AA) recurrence or treating symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF) compared … [Read more...] about Boston Scientific Farapulse PFA system shows superiority in head-to-head study with Medtronic cryoablation system
Supira Medical closes $120M Series E, completes enrollment in ventricular assist device study
Supira Medical announced today that it completed an oversubscribed Series E financing round, bringing in $120 million. The clinical-stage Shifamed portfolio company also recently completed enrollment for its U.S. SUPPORT I Early Feasibility Study (EFS) evaluating its percutaneous ventricular assist device (pVAD) for treating high-risk … [Read more...] about Supira Medical closes $120M Series E, completes enrollment in ventricular assist device study
Evident Vascular closes Series B for AI-powered intravascular ultrasound
Evident Vascular announced today that it closed a Series B financing round to support its AI-powered intravascular ultrasound (IVUS) platform. The San Jose, California–based company did not disclose the amount raised in the Series B round. It adds to $35 million picked up in a Series A that brought the company out of stealth mode in 2023. … [Read more...] about Evident Vascular closes Series B for AI-powered intravascular ultrasound
Abbott is making an IVL play with FDA IDE nod
Abbott announced today that it received FDA investigational device exemption (IDE) approval for its coronary intravascular lithotripsy (IVL) system. IDE enables the company to evaluate the system in treating severe calcification in coronary arteries prior to stenting. The company expects its TECTONIC coronary artery disease (CAD) IVL trial to … [Read more...] about Abbott is making an IVL play with FDA IDE nod
How Shockwave’s Javelin IVL catheter breaks up blood-blocking calcium where balloons can’t reach
Shockwave’s novel Javelin intravascular lithotripsy catheter focuses acoustic energy forward to clear a path through calcium-clogged blood vessels. Johnson & Johnson MedTech’s Shockwave Medical aims to deliver intravascular lithotripsy (IVL) to a different type of blood vessel with a first-of-its-kind catheter platform. The Javelin … [Read more...] about How Shockwave’s Javelin IVL catheter breaks up blood-blocking calcium where balloons can’t reach
Medtronic recalls embolization device after reported deaths
The FDA deemed a recall of some Medtronic Pipeline Vantage embolization devices serious after multiple deaths related to the device. The recall involves removing Pipeline Vantage 027 device models from use and sale and updating instructions for Pipeline Vantage 021 models. Medtronic's Pipeline Vantage embolization devices with Shield Technology … [Read more...] about Medtronic recalls embolization device after reported deaths
Perfuze wins FDA nod for access catheter, raises $24M
Perfuze announced today that it received FDA 510(k) clearance for its Zipline access catheter and secured significant funding. The Galway, Ireland–based medtech company picked up about $24 million (€22 million) in a follow-on funding round. Existing investors, including Earlybird, EQT Life Sciences, Seroba and SV Health, participated in the … [Read more...] about Perfuze wins FDA nod for access catheter, raises $24M
NanoVibronix announces reverse stock split
NanoVibronix (Nasdaq:NAOV) announced today that it intends to effect a reverse stock split of its common stock. The split comes at a ratio of one post-split share for every 11 pre-split shares. Tyler, Texas-based NanoVibronix expects the split to go into effect at 4:05 p.m. on March 13, 2025. It plans for its common stock to continue trading on … [Read more...] about NanoVibronix announces reverse stock split
Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
Second Heart Assist today announced data from a study highlighting the performance of its Whisper device against a competitive heart pump. The study showed that Whisper — a next-generation percutaneous mechanical circulatory support (pMCS) system — caused significantly less hemolysis than the widely used Johnson & Johnson MedTech/Abiomed … [Read more...] about Second Heart Assist says Whisper device caused less hemolysis compared to Abiomed Impella CP
