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 […]
Edwards Lifesciences warns on risk of IntraClude balloon bursting
Edwards Lifesciences (NYSE:EW) issued a field safety notice warning users that its IntraClude balloon could burst during cardiopulmonary bypass. The high-risk balloon burst could cause injury, according to the company. When the balloon bursts, the heart can fill and warm and obscure the operative site. Edwards Lifesciences says the device needs to be exchanged or operate […]
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 […]
HeartFlow adds another $65m
HeartFlow added another $65 million to its coffers for the heart function analysis it developed. Redwood City, Calif.-based HeartFlow, which developed the FFRct fractional flow reserve analysis, said it hopes to raise another $35 million in the equity round. Nine unnamed investors participated, with the first sale occurring June 11,HeartFlow said in a regulatory filing. […]
FDA clears CorMatrix Cardiovascular’s Cor heart tissue patch
CorMatrix Cardiovascular said it received FDA 510(k) clearance for its Cor Patch epicardial patch. The Cor Patch epicardial patch is designed to repair the atria and the left and right ventricular walls of the heart that are thin or damaged as a result of myocardial infarct. “We have a unique opportunity to enhance the repair […]
Materialise wins FDA clearance for 3D modeling software for cardio procedures
Materialise said today that FDA has provided 510(k) clearance for its Mimics Enlight — a cardiovascular procedure planning software creating accurate 3D printed heart models. The Belgian 3D printing software and services company, which has its U.S. offices in Plymouth, Minn., plans the first release of the software to focus on planning for complex transcatheter […]
Zoll buys AED developer Cardiac Science
Zoll Medical said today that it inked a deal to acquire Cardiac Science Corp., and its portfolio of automated external defibrillators. Deerfield, Wis.-based Cardiac Science operates in North America, Europe and Asia. The company has installed more than 500,000 units in nearly 100 countries, according to Zoll. The two companies did not disclose financial terms […]
Want to save your medical device as a souvenir? It’s easier than you might think
Keeping a medical device that was inside you — or even a removed body part — is actually easier than it might seem, according to a recent story in the Chicago Tribune. Just ask Barbara Brotman. Brotman is a senior assistant director of development communications for University of Chicago Medicine and Biological Sciences and a […]
Biotronik touts success of its resorbable magnesium scaffold
Biotronik said today that new data from a European patient registry strengthen the clinical evidence for its Magmaris resorbable scaffold device, its procedure success and safety profile. The target lesion failure (TLF) rate at 12 months was 4.7%. Cardiac death occurred in 0.1% of the 800 patients who received Magmaris and scaffold thrombosis in 0.6%. […]
FDA clears Gore’s Cardioform ASD occluder
W.L. Gore & Associates said today that it won FDA premarket approval for its Gore Cardioform ASD occluder designed for the percutaneous closure of ostium secundum atrial septal defects. Approval came supported by data from the pivotal stage of Flagstaff, Ariz.-based Gore’s ASSURED clinical study, which reported a 100% closure success rate at six months post-implant. […]
Ancora Heart launches 2nd AccuCinch ventricular repair system feasibility study
Ancora Heart said yesterday that it launched a U.S.-based early feasibility study looking to evaluate its AccuCinch ventricular repair system intended for treating patients with reduce ejection fraction systolic heart failure. The first patient has already been enrolled in the study at UPMC Pinnacle Harrisburg by Dr. Hemal Gada and Dr. Mubashir Mumtaz, Santa Clara, […]
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