Endotronix last week announced that it received FDA approval to begin its multi-center Proactive-HF trial of the Cordella Pulmonary Artery Pressure Sensor System. The trial is designed to help the Cordella Sensor reach pre-market approval faster and will begin enrollment in the third quarter of 2019. “We are excited to begin enrollment in this groundbreaking […]
Vascular Graft Solutions wins CE Mark for fistula repair device
Vascular Graft Solutions today announced that it received CE Mark approval for its Frame FR external support for AV fistula repair. “We are excited to launch the Frame FR platform, a holistic solution for repair, stabilization and prevention of recurrent vascular access disease,” founder and CEO Eyal Orion said in a press release. “In the […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according […]
SentreHeart touts first-in-human Lariat procedures with EpiRail
SentreHeart yesterday touted the first-in-human procedures involving its Lariat left atrial appendage closure device to reduce the risk of stroke in patients with atrial fibrillation. The initial nine procedures, performed by Drs. Kryzstof Bartus and Randy Lee at Krakow, Poland’s John Paul II hospital, used the EpiRail vacuum stabilization system for an epicardial-only, percutaneous approach […]
Humana sues Abbott’s St. Jude Medical over CRM batter
Humana (NYSE:HUM) leveled a lawsuit against Abbott (NYSE:ABT) subsidiary St. Jude Medical seeking to recoup payments it made for cardiac rhythm management devices that were later recalled due to a battery issue. In October 2016 St. Jude publicly revealed the risk that the lithium-based batteries used in its implantable cardioverter defibrillators and cardiac resynchronization therapy […]
Medtronic’s VenaSeal now available in India
Medtronic (NYSE:MDT) said today that it has launched the VenaSeal closure system in India for patients with chronic venous disease. VenaSeal is used in a minimally invasive procedure that uses a proprietary medical adhesive to close the diseased veins. Using ultrasound, the physician guides a catheter through a small access site in the leg and […]
Ablacon raises another $12m
Ablacon (Menlo Park, Calif.) announced this week that it has secured a $10 million venture debt facility from Western Technology Investment (WTI), accompanied by a $2 million equity investment. The money will help fund the first multicenter randomized clinical trial for Ablamap, Ablacon’s mapping system to guide the treatment of people with atrial fibrillation. “WTI […]
Edwards Lifesciences abandons Centera self-expanding TAVR for Sapien 3 Ultra push
Edwards Lifesciences (NYSE:EW) is discontinuing work on its Centera TAVR system as it increases focus on expanding indications for its Sapien 3 Ultra valve. The news — which came yesterday with the company’s second-quarter earnings announcement — comes weeks after an urgent field safety notice in which the company warned customers that it had received reports […]
Neovasc eyes early 2020 for Reducer’s U.S. debut
Neovasc (NSDQ:NVCN) this week said it hopes to get its Reducer device for treating angina on the U.S. market early next year. That all hinges on the FDA, however, which must still grant humanitarian use device status to Reducer, which is designed to narrow the coronary sinus, and approve a humanitarian device exemption for treating […]
The 17 most innovative medical devices of 2019
The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Edwards Lifesciences warns on burst balloon risk with Sapien 3 Ultra heart valve
Edwards Lifesciences (NYSE:EW) warned doctors about the low risk of burst balloons during implantation of its Sapien 3 Ultra replacement heart valve, cautioning physicians to closely follow the instructions for use to avoid the problem. The Irvine, Calif.-based medical device maker’s latest iteration of its transcatheter aortic valve replacement won CE Mark approval in the European […]
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