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
Lubrizol partners with Polyhose on medical tubing plant in India
Lubrizol (Wickliffe, Ohio) announced today that it will work with Polyhose (Wilmington, North Carolina) to create a medical tubing plant in Chennai, India's home state of Tamil Nadu. The new site enables Lubrizol to boost its local medical tubing volume five-fold. The tubing will go toward neurovascular and cardiovascular medical applications, … [Read more...] about Lubrizol partners with Polyhose on medical tubing plant in India
Otsuka partners with ICU Medical to enter U.S. IV products market
Otsuka Holdings will pay ICU Medical (Nasdaq: ICUI) an upfront payment of $200 million as part of a joint venture to enter the U.S. IV products market, which has been facing hurricane-related shortages this fall. The partnership — which involves ICU Medical providing commercial services for Otsuka’s Otsuka Pharmaceutical Factory (OPF) … [Read more...] about Otsuka partners with ICU Medical to enter U.S. IV products market
Boston Scientific to acquire Cortex and its cardiac mapping tech
Boston Scientific (NYSE: BSX) announced today that it will purchase Ajax Health's Cortex and its FDA-cleared OptiMap system to guide physicians performing ablation procedures to treat AFib Financial terms of the deal were not disclosed. Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing … [Read more...] about Boston Scientific to acquire Cortex and its cardiac mapping tech
Scientia Vascular raises $14M for neurovascular treatment tech
Scientia Vascular announced today the successful completion of a $14 million growth financing round. West Valley City, Utah–based Scientia says the money will enable it to continue commercializing what company officials describe as the next generation of neurovascular tools, providing new ways to treat a variety of neurovascular disease … [Read more...] about Scientia Vascular raises $14M for neurovascular treatment tech
Teleflex wins FDA clearance for perfusion balloon for PTCA
Teleflex (NYSE: TFX) announced today that the FDA has granted 510(k) clearance for the company's Ringer perfusion balloon catheter for percutaneous transluminal coronary angioplasty (PTCA). The clearance expands Wayne, Pennsylvania–based Teleflex's interventional cardiology portfolio. It enables the company to offer what it says is the only … [Read more...] about Teleflex wins FDA clearance for perfusion balloon for PTCA
InnovHeart has first in-human implantation of its TMVR
InnovHeart (Newton, Massachusetts and Milan) announced the first trans-septal clinical trial implant of its proprietary Saturn transcatheter mitral valve. According to the company, there were excellent hemodynamic results for the patient — a 79-year-old woman suffering from severe mixed (degenerative and functional) mitral regurgitation. The … [Read more...] about InnovHeart has first in-human implantation of its TMVR
Stereotaxis to acquire Access Point Technologies and its EP catheters
Stereotaxis (NYSE: STXS) is purchasing a Minneapolis-based electrophysiology (EP) catheter maker to further enhance its minimally invasive endovascular surgical robotics technology. St. Louis–based Stereotaxis did not disclose how much it is paying for Access Point Technologies in its after-hours news release. The transaction, paid with … [Read more...] about Stereotaxis to acquire Access Point Technologies and its EP catheters
Medtronic pulsed field ablation system wins approval in Japan
Medtronic (NYSE: MDT) announced today that its PulseSelect pulsed field ablation (PFA) system has won regulatory approval in Japan. The regulatory nod in Japan further expands the reach of the system, which in December became the first PFA system approved in the United States to treat paroxysmal and persistent atrial fibrillation (AFib). Since … [Read more...] about Medtronic pulsed field ablation system wins approval in Japan
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system. The embolic can block or occlude blood flow to specific blood … [Read more...] about Boston Scientific has a serious recall involving embolization tech