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
Cardiology
FDA clears Imperative Care’s Symphony 16F 82cm catheter
Imperative Care today announced FDA 510(k) clearance of its Symphony 16 Fr 82cm catheter for venous thrombosis and announced the first successful cases. Campbell, California-based Imperative Care said the catheter joins the Symphony Thrombectomy System's 16 Fr 117 cm and 24 Fr 85 cm catheters. "The customized length of the 16 Fr 82 cm … [Read more...] about FDA clears Imperative Care’s Symphony 16F 82cm catheter
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
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
Medtronic says new study backs Prevail paclitaxel-coated balloon
Medtronic (NYSE: MDT) announced results from a registry highlighting the effectiveness of the Prevail drug-coated balloon (DCB). Dr. Sacharias von Koch of the Deptartment of Cardiology and Clinical Sciences at Lund University, Skåne University Hospital in Sweden presented findings from the Swedish Coronary Angiography and Angioplasty Registry … [Read more...] about Medtronic says new study backs Prevail paclitaxel-coated balloon
Reflow Medical expands global reach with European subsidiary
Reflow Medical announced today that it opened a European subsidiary in Landsberg am Lech, Germany, to expand outside the U.S. The company said its strategic expansion strengthens its international presence and enhances its ability to serve markets globally. SVP and GM Knut Saurteig leads the subsidiary, called Reflow Medical Europe GmbH. … [Read more...] about Reflow Medical expands global reach with European subsidiary
Olympus launches single-use hemostasis clip
Olympus announced that it launched a new hemostasis clip to meet the needs of gastrointestinal (GI) endoscopists. The company's Retentia HemoClip offers 360° rotation and an intuitive one-step deployment. This provides control over placement with three different sizes to accommodate a variety of closure applications. Retentia HemoClip … [Read more...] about Olympus launches single-use hemostasis clip
J&J’s Shockwave Medical launches new IVL catheter
Johnson & Johnson MedTech‘s Shockwave Medical today announced the U.S. launch of its Javelin peripheral intravascular lithotripsy (IVL) catheter. The system is designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). Shockwave said its novel, non-balloon IVL platform delivers a similar … [Read more...] about J&J’s Shockwave Medical launches new IVL catheter
Boston Scientific to acquire renal denervation company SoniVie
Boston Scientific (NYSE:BSX) announced today that it agreed to acquire intravascular ultrasound system developer SoniVie. Marlborough, Massachusetts-based Boston Scientific is a strategic investor in SoniVie, holding about a 10% equity stake. With this stake, the transaction features an upfront payment of approximately $360 million for the 90% … [Read more...] about Boston Scientific to acquire renal denervation company SoniVie
Adagio Medical to restructure, reduce workforce
Adagio Medical (Nasdaq:ADGM) announced today that it plans a corporate restructuring and realignment of resources. The Laguna Hills, California–based company, which develops catheter ablation technologies for treating cardiac arrhythmias, wants to prioritize its FULCRUM-VT pivotal FDA investigational device exemption (IDE) clinical trial … [Read more...] about Adagio Medical to restructure, reduce workforce
