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 […]
Catheters
Abbott wins FDA approval for its fourth-generation MitraClip
Abbott (NYSE:ABT) announced today that U.S. FDA has approved the MitraClip G4, the most advanced version yet of the company’s transcatheter heart valve repair device to treat mitral regurgitation. Abbott expanded the number of clip sizes to four for the MitraClip G4, including clips with a wider grasping area, in order to expand the treatment options […]
Deaths prompt Class I recall for Edwards Lifesciences IntraClude balloon
The FDA, prompted by multiple reports that the Edwards Lifesciences (NYSE:EW) IntraClude balloon burst that included three deaths, yesterday gave the device’s recall Class I status. The IntraClude device is designed to occlude the aorta during cardiopulmonary bypass procedures. Last month, Irvine, Calif.-based Edwards put out a field safety notice about the high-risk balloon bursts, which […]
Innovative Health lands another catheter reprocessing clearance
Innovative Health said today that it has received FDA clearance to reprocess the Biosense Webster PentaRay Nav eco high-density mapping catheter for reuse. The clearance is the latest allowing Scottsdale, Ariz.-based Innovative Health to reprocess catheters. The FDA cleared it in 2018 to reprocess St. Jude Medical’s Advisor FL, Medtronic’s Torqr and Marinr and Biosense Webster’s […]
InterVene raises $15m Series B for BlueLeaf venous valve repair device
InterVene said today that it raised a $15 million Series B round for the venous valve repair device it’s developing. South San Francisco-based InterVene touts BlueLeaf as the first catheter-based treatment for deep vein reflux that doesn’t use an implant. It’s designed to form new venous valves using vein wall tissue, the company said. The […]
JenaValve adds $15m for TAVR device
JenaValve Technology said yesterday that it raised nearly $15 million for the transcatheter aortic valve replacement it’s developing. The Irvine, Calif.-based company makes the the Everdur valve and Coronatix delivery catheter to treat aortic stenosis and aortic regurgitation. In a regulatory filing, JenaValve said it pulled in $14.5 million in an equity round that began […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Acutus Medical reels in $170m
Acutus Medical said today that it pulled down $170 million in financing from its Series D offering and a new credit line for the cardiac mapping technology it developed. In addition to its AcQMap tech to aid in ablation treatment of arrhythmias, Carlsbad, Calif.-based Acutus makes a line of vascular access products. It’s latest financing […]
Cook Medical recalls peripheral catheters on burst balloon risk
Cook Medical recalled 12 lots of one of its peripheral catheters on reports of balloons bursting at pressures below the rated burst pressure. In a May 24 field advisory, Bloomington, Ind.-based Cook said it received “multiple” complaints about burst balloons in its Advance Enforcer 35 Focal Force PTA balloon catheters, which are designed to treat […]
Zoll acquires TherOx
Zoll Medical said today that it acquired TherOx and its acute myocardial infarction treatment. TherOx’s SuperSaturated Oxygen Therapy system delivers a 60-minute infusion of the patient’s super-oxygenated blood to a targeted ischemic area of the heart via a small catheter. The treatment is designed to improve microvascular flow and reduce infarct size following primary coronary […]
50 medtech startups you need to know
Medical device industry accelerator MedTech Innovator today announced about 50 medtech startups participating in its annual four-month program. Half are early-stage companies participating in MedTech Innovator’s Accelerator and Showcase program, and the other half are mid-stage companies in the organization’s Showcase program. The list of companies is a who’s who of people around the world […]