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
Nitinol
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
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
Experts from Medtech Big 100 device developers — Medtronic, Johnson & Johnson MedTech, Abbott and Boston Scientific — discuss the various shapes of their pulsed field ablation (PFA) catheters. From flowers and loops to globes, baskets and balloons, there's no standard shape for the pulsed field ablation (PFA) catheters coming out of Medtronic, … [Read more...] about Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
How Medtronic designed the PulseSelect pulsed field ablation system for AFib
Medtronic‘s PulseSelect became the first pulsed field ablation (PFA) system to win FDA approval for treating atrial fibrillation (AFib) in December 2023. The world’s largest medical device manufacturer achieved that milestone about 15 years after one of its engineers, Mark Stewart, coined the term “pulsed field ablation” in a research paper … [Read more...] about How Medtronic designed the PulseSelect pulsed field ablation system for AFib
This medtech developer is throwing everything at clots
Retriever Medical is developing a thrombectomy system with a four-front approach for treating blood clots. The Las Vegas-based startup calls its technology VORS AMD, for vascular occlusion removal system with aspiration, mechanical and drug delivery. The approach combines nitinol baskets for mechanical thrombectomy with aspiration, clot-busting … [Read more...] about This medtech developer is throwing everything at clots
First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks
The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that's unique within Medtronic's PFA device portfolio.
Medtronic recently offered a first look at its Sphere-360 pulsed field ablation (PFA) and mapping catheter, an investigational device with some design features that are new for the world's largest device manufacturer.
In an interview with Medical Design & Outsourcing, Tim Laske, VP of research and business development for Medtronic Cardiac … [Read more...] about First look: Medtronic’s Sphere-360 pulsed field ablation catheter design has some new tricks The investigational Medtronic Sphere-360 pulsed field ablation and mapping catheter uses nitinol for a feature that's unique within Medtronic's PFA device portfolio.
