Keystone Heart this week said it won CE mark approval for its TriGuard 3 Cerebral Embolic Protection device. TriGuard 3 is designed to reduce the risk of cerebral damage by deflecting debris from cerebral circulation during trans catheter aortic valve implantation and other transcatheter heart procedures, according to the company. “Even with increased operator experience […]
Supira Medical closes $35m Series B for its pVAD tech
Supira Medical announced that it closed a $35 million Series B financing round and appointed Nitin Salunke as its new president & CEO. Cormorant Asset Management led the financing, which officially closed on Feb. 25. The Capital Partnership, 415 Capital, AMED Ventures and Shifamed Angels all participated as well. Campbell, Calif.-based Supira Medical said in […]
CryoLife wins CE mark for E-vite Open NEO stent graft system
CryoLife Inc. (NYSE:CRY) this week said it won CE mark approval for the E-vita Open NEO hybrid stent graft system to treat aortic arch disease. The hybrid stent graft technologies allow for a one-stage procedure treatment of this condition by combining the surgical arch repair and endovascular descending thoracic repair. “We are pleased to have received […]
Abbott wins CE Mark for FlexNav delivery system
Abbott (NYSE:ABT) announced today that it won CE Mark approval in Europe for the FlexNav delivery system for its Portico transcatheter aortic valve implantation (TAVI) system. The Abbott Park, Ill.-based company’s FlexNav delivery system is designed to offer another tool for doctors to treat patients requiring a transcatheter aortic valve implant by incorporating stability, predictability and […]
V-Wave lands CE Mark for heart-failure device
V-Wave announced today that its Ventura interatrial shunt system has received the CE Mark. The Caesarea, Israel-based company’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500-patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who […]
Neovasc to seek CE Mark for Tiara transapical mitral valve repair device
Neovasc (NSDQ:NVCN) announced that it plans to win CE Mark approval for its TA Tiara under the new European Medical Device Regulation (EU MDR) by 2021 or earlier. The company said it has treated 82 patients to date with the transapical (TA) Tiara mitral valve repair device. After reviewing the clinical data from its Tiara I […]
Is Medtronic eyeing LivaNova for a takeover?
Some industry analysts are speculating that Medtronic (NYSE:MDT) might want to acquire LivaNova (NSDQ:LIVN) for its neuromodulation business. A source told financial intelligence company Reorg last week that someone pitched the idea to Medtronic, which would divest LivaNova’s cardiovascular business and “certain MDT cardiac surgery products.” “Five sector advisors said such a deal would make sense as […]
CryoLife wins CE Mark for ascending aortic prosthesis
CryoLife Inc. (NYSE:CRY) announced that it received CE Mark approval for the On-X ascending aortic prosthesis (AAP) for treating native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. The approval allows for resumed distribution of the On-X AAP in Europe, as the product has been off the market there since late […]
CHF Solutions wins FDA nod for Aquadex SmartFlow pediatric indication
CHF Solutions (NSDQ:CHFS) announced today that it received FDA 510(k) clearance for its next-generation Aquadex SmartFlow console for use in adult and pediatric patients weighing 20 kg or more. Eden Prairie, Minn.–based CHF Solutions said it submitted an application for clearance for the next-generation console last month, having previously offered its Aquadex FlexFlow system that wasn’t […]
LivaNova beats on Q4 earnings, misses on revenue
LivaNova (NSDQ:LIVN) shares took a slight dip today on fourth-quarter results that beat the consensus projections for earnings but came up short on revenue. The London-based medical device company posted losses of -$143.2 million, or -$2.96 per share, on sales of $287.6 million for the three months ended Dec. 31, 2019, for a 32% bottom-line gain […]
PhysIQ touts VA study showing AI predicting hospitalizations
PhysIQ today is touting results from a study testing the ability to detect heart failure exacerbation using wearable sensors and personalized analytics based on artificial intelligence. The Link-HF study set out to assess the ability to predict rehospitalization due to heart failure exacerbation using analytics applied to continuous wearable sensor data, according to a news […]
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