Miracor Medical said today that it received breakthrough designation from the FDA for its PiCSO device for treating a type of heart attack. The PiCSO (pressure-controlled intermittent coronary sinus occlusion) system is designed to clear coronary microcirculation by intermittently stopping the delivery of blood through the coronary sinus into the right atrium. The intended result […]
FDA OKs Adagio Medical’s cryoablation afib trial
Adagio Medical yesterday said it received an investigational device exemption from the FDA for a clinical trial of its cryoablation device for treating atrial fibrillation. The 80-patient study, a non-randomized, single-arm trial of subjects with persistent afib, will use the Laguna Hills, Calif.-based company’s intelligent continuous lesion ablation system to treat patients with afib of […]
Transcatheter mitral valve tech dev CardioMech AS raises $5m
CardioMech AS said today that it has raised another $5 million in a heavily oversubscribed convertible note funding round, bringing its total raised during 2019 to $7.5 million. Experienced medtech investors participated in the round, whose proceeds will be used to further accelerate the development of its transcatheter mitral valve technology, according to the early-stage […]
Perfuze lands breakthrough designation for Millipede clot ingestion system
Perfuze yesterday announced that the FDA granted its Millipede CIS technology Breakthrough Device Designation. Millipede CIS is a catheter technology that removes clots from the brain after an acute ischemic stroke. The Breakthrough Device Designation was granted based on its potential to offer advantages over other alternative treatment of acute ischemic stroke, according to 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 […]
Integra Lifesciences picks up Arkis Biosciences
Integra LifeSciences (NSDQ:IART) this week acquired Arkis BioSciences and its line of neurosurgery devices for an undisclosed amount. Knoxville, Tenn.-based Arkis makes the CerebroFlo external ventricular drainage catheter that uses its Endexo anti-thrombus additive to prevent blood clots. “Neurocritical care is an important area of focus for Integra. We recently introduced our CereLink intracranial pressure monitor […]
Bioventrix adds $18m
BioVentrix added some $18 million to the $21.8 million it raised earlier this year, according to a regulatory filing. The San Ramon, Calif.-based company said it pulled down a total of $40 million in the round from 162 unnamed investors, after reporting the earlier raise in April. The first sale was logged in August 2017, […]
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 […]
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 […]
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