Cook Medical has issued a letter to customers recommending the removal of certain sizing catheters from where they are used or sold. Affected devices include the company's Centimeter, Aurous Centimeter and Beacon Tip Centimeter sizing catheters. (The FDA website contains a full list of affected lots.) Sizing catheters offer use in … [Read more...] about Cook Medical warns on certain sizing catheters
Catheters
Pulse Biosciences names Liane Teplitsky as new COO
Pulse Biosciences (Nasdaq:PLSE) announced today that it appointed Liane Teplitsky as its new COO to further bolster its leadership team. Hayward, California-based Pulse Biosciences also expanded the role of Dr. David Kenigsberg to full-time chief medical officer (CMO). The pulsed field ablation (PFA) technology developer says the appointments … [Read more...] about Pulse Biosciences names Liane Teplitsky as new COO
Adagio Medical wins FDA IDE to expand ventricular ablation study to use next-gen catheter
Adagio Medical (Nasdaq:ADGM) announced today that it received FDA investigational device exemption (IDE) to expand its FULCRUM-VT trial. FULCRUM-VT evaluates the company's vCLAS cryoablation technology for treating cardiovascular disease. Laguna Hills, California-based Adagio built its vCLAS cryoablation catheter on its proprietary ultra-low … [Read more...] about Adagio Medical wins FDA IDE to expand ventricular ablation study to use next-gen catheter
Okami Medical enrolls first patient in vascular occlusion registry
Okami Medical announced that it enrolled the first patient in the ALPHA Registry evaluating its LOBO vascular occlusion system. The company designed LOBO (low-profile braided occluder) to provide controlled mechanical occlusion of peripheral vessels. It works across a broad range of anatomies. The ALPHA Registry evaluates LOBO in patients with a … [Read more...] about Okami Medical enrolls first patient in vascular occlusion registry
InVera wins FDA clearance for non-thermal infusion catheter
InVera Medical announced today that it received FDA 510(k) clearance for its InVera Infusion Device. Galway, Ireland-based InVera designed its minimally invasive device to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. It aims to treat chronic venous disease (CVD), which currently faces a … [Read more...] about InVera wins FDA clearance for non-thermal infusion catheter
Route 92 Medical brings in $50M growth financing
Route 92 Medical announced today that it secured $50 million in growth financing to support its neurovascular intervention offerings. New investor Sectoral Asset Management joined lead investor Novo Holdings in the financing. Existing investors U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners and the Vertical Group … [Read more...] about Route 92 Medical brings in $50M growth financing
Pulse Biosciences enrolls first patient in IDE study for PFA tech
Pulse Biosciences (Nasdaq:PLSE) announced today that it enrolled the first patients in its NANOPULSE-AF study. NANOPULSE-AF, an FDA investigational device exemption (IDE) study, evaluates the nPulse cardiac catheter system in the treatment of recurrent, drug-resistant, symptomatic paroxysmal AFib. Hayward, California-based Pulse Biosciences … [Read more...] about Pulse Biosciences enrolls first patient in IDE study for PFA tech
E2 raises $80M Series C for Hēlo thrombectomy system
Endovascular Engineering (E2) announced today that it raised $80 million in an oversubscribed Series C financing round. Gilde Healthcare and Norwest co-led the latest financing for the Menlo Park, California–based company. Existing investors, including Santé Ventures, 415 Capital, S3 Ventures, Panakès Partners, M&L Healthcare Investments, … [Read more...] about E2 raises $80M Series C for Hēlo thrombectomy system
Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe
Johnson & Johnson (NYSE:JNJ) announced today that it launched the Varipulse Pro system in Europe following CE mark approval. Varipulse Pro features a new pulse sequence that marks the next evolution of the pulsed field ablation (PFA) platform. The company said it designed the technology to improve procedural efficiency while reinforcing … [Read more...] about Johnson & Johnson brings next-gen Varipulse PFA catheter to Europe
MicroPort EP wins European approval for PFA catheter
MicroPort EP announced today that it received EU MDR certification for its PulseMagic pulsed field ablation (PFA) catheter. The China-based company designed its PFA catheter to enhance both flexibility and performance in electrophysiology (EP) procedures. MicroPort says that PulseMagic enables both high-density mapping and PFA through one … [Read more...] about MicroPort EP wins European approval for PFA catheter
