Surmodics (Nasdaq:SRDX) today announced the successful early clinical use of its Pounce XL thrombectomy system. The early use comes as part of a limited market release. Surmodics plans for a full commercial launch planned for after the initial rollout. Pounce XL received FDA 510(k) clearance in September 2024. Dr. Walter Rizzoni used the system … [Read more...] about Surmodics reports first clinical use of thrombectomy system
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Zeus to launch next-gen film-cast PTFE catheter liners
NEWS RELEASE: Zeus to launch next-gen film-cast PTFE liners engineered for flexibility and superior strength Unveiling at MD&M West, the new StreamLiner NG catheter liners minimize defects and maximize performance versus existing film-cast PTFE liners. Orangeburg, S.C. – Zeus, a global leader in advanced polymer solutions and catheter … [Read more...] about Zeus to launch next-gen film-cast PTFE catheter liners
FDA approves Merit Medical’s cell-impermeable endoprosthesis
Merit Medical Systems (Nasdaq:MMSI) announced today that it received FDA premarket approval for its Wrapsody cell-impermeable endoprosthesis. With approval, the company can begin commercializing the device in the U.S. in 2025. South Jordan, Utah–based Merit Medical designed Wrapsody to extend long-term vessel patency in dialysis patients. It … [Read more...] about FDA approves Merit Medical’s cell-impermeable endoprosthesis
First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Flow Medical is developing a thrombolysis catheter to improve the treatment of blood clots in pulmonary embolism patients. The Chicago-based startup designed its minimally invasive system with a novel nitinol scaffold that perforates blood clots and infuses them with tissue plasminogen activator (TPA), a thrombolytic drug commonly referred to as … [Read more...] about First Look: Flow Medical’s next-generation thrombolysis catheter for pulmonary embolism
Medtronic acquires articulating instrument maker Fortimedix Surgical
Fortimedix Surgical announced today that it has been acquired by medtech giant Medtronic (NYSE:MDT). "We are pleased to share that Fortimedix Surgical was acquired by Medtronic," the company wrote on LinkedIn. "A unique opportunity to leverage our articulating instrument technology for application across patient therapies. We look forward to … [Read more...] about Medtronic acquires articulating instrument maker Fortimedix Surgical
Second Heart Assist’s Whisper device has successful case studies
Second Heart Assist (Salt Lake City) today announced successful case studies in South America with its Whisper catheter-delivered heart assist device. Dr. Adrian Ebner, head of the cardiovascular department at the Sanatorio Italiano Hospital in Asuncion, Paraguay, and his team completed non-randomized case studies involving six patients. Second … [Read more...] about Second Heart Assist’s Whisper device has successful case studies
Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges
Solaris Endovascular today announced its formation to develop solutions for dialysis access and treating peripheral artery disease (PAD). The New Orleans-based company develops technologies to treat and extend the patency of dialysis access fistulae, grafts, and peripheral arteries. It aims to enable patients to lead healthier lives with fewer … [Read more...] about Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges
FDA clears Surmodics’ Pounce XL thrombectomy system
Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter. That makes it suitable for iliac, femoral, and other arteries within this … [Read more...] about FDA clears Surmodics’ Pounce XL thrombectomy system
Edwards launches Sapien 3 valve with Alterra prestent in Europe
Edwards Lifesciences (NYSE:EW) announced that it launched its Sapien 3 transcatheter pulmonary valve implant (TPVI) system with Alterra adaptive prestent in Europe. The launch expands the continent’s minimally invasive treatment options to a broader range of patients with congenital heart conditions. Edwards recently received CE mark for … [Read more...] about Edwards launches Sapien 3 valve with Alterra prestent in Europe
InspireMD submits carotid stent for FDA premarket approval
InspireMD (Nasdaq:NSPR) announced today that it submitted a premarket approval (PMA) application to the FDA for its CGuard system. The company designed the CGuard Prime carotid stent system, made from nitinol, for the treatment of carotid artery stenosis. It based its PMA application on positive one-year data from the company's C-GUARDIANS … [Read more...] about InspireMD submits carotid stent for FDA premarket approval
