European regulators have approved the delivery of Medtronic‘s CoreValve System using a new direct aortic approach in patients with severe aortic stenosis. Transcatheter aortic valve implantation (TAVI) is a less-invasive alternative to open-heart surgery for aortic valve replacement, but some patients are unsuited for the procedure because they have small vessels. The newly CE Marked […]
Cardiac device maker AtriCure (NASDAQ:ATRC) saw its stock plunge Monday after an FDA report expressed “concerns” about a clinical trial for one of the company’s ablation devices. U.S. Food and Drug Administration staffers issued a (pdf) report in advance of an FDA advisory panel’s Wednesday meeting to review AtriCure’s application for approval of an atrial […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
St. Jude Medical (NYSE:STJ) this week rolled out one of its heart imaging products in India: the C7-XR Optical Coherence Tomography (OCT) Intravascular Imaging System with the C7 Dragonfly Imaging Catheter. It’s a natural addition to the St. Jude product line in the country. The imaging system is used by interventional cardiologists to help with […]
A Medtronic (NYSE:MDT) device that treats chronic high blood pressure by delivering radio frequency to the kidney has topped Cleveland Clinic‘s list of the Top Medical Innovations for 2012. The device, which Medtronic acquired through its $800 million acquisition of Ardian earlier this year, is called the (pdf) Symplicity Catheter System. It works via a […]
Abbott Vascular’s Ferolyn Powell talks about the company’s MitraClip technology, which is used to treat a common heart valve condition called mitral regurgitation. The MitraClip device is designed to reduce significant mitral regurgitation by clipping together the leaflets of the mitral valve, one of the four valves of the heart. Powell, vice president and general […]
Ohio State University spinoff EXCMR is preparing for a fourth-quarter launch of a four-site clinical test of its MRI-compatible treadmill for heart-stress testing. The clinical test’s chief goal is to compare the performance of the company’s stress test against competing alternatives and fine-tune the treadmill’s design, plus its installation and servicing processes. “Launching this pilot […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
A cardiac medical device from Sunshine Heart that uses a balloon to assist the heart in pumping blood has shown promise in a clinical trial led by Ohio State University Medical Center (OSUMC). Patients enrolled in a multicenter North American clinical trial of Eden Prairie, Minnesota-based Sunshine Heart’s C-Pulse heart-assist system saw improvement in a […]
A U.S. Food and Drug Administration panel will review cardiac device maker AtriCure‘s (NASDAQ:ATRC) application for a label for the surgical treatment of atrial fibrillation. On Oct. 26, the FDA’s Circulatory System Devices Panel will review the Cincinnati-area device maker’s Premarket Approval Application (PMA) for its Synergy ablation system, according to a statement from West […]
Heart test-maker CardiOx has closed an $8 million series C round of investment that the company plans to use to begin U.S. and European commercialization. The round was led by Michigan-based Lifeline Ventures, a new investor in Columbus, Ohio-based CardiOx, and included contributions from existing investors Early Stage Partners, Glengary and Reservoir Partners, CardiOx CEO […]
Medtronic (NYSE:MDT) announced this week that its transcatheter aortic valve implantation (TAVI) system — CoreValve — had positive clinical outcomes in the longest, post-market follow-up in a published study of any TAVI device. The device is designed to replace a diseased aortic valve without open-heart surgery. The clinical trial of the heart valve catheter product […]
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Biomarker test-maker Cleveland HeartLab has closed an $18.4 million series B round of funding, which was led by two Boston-area investors. The size of the round is a testament to the explosive growth that the young company has achieved in less than two years of existence after being spun out from Cleveland Clinic — and […]
A Minnesota startup is hoping that its heart assist device will provide an alternative to congestive heart failure patients using traditional ventricular assist devices to help the heart pump blood properly. NeoCardial Technologies is getting ready to begin animal trials on its extra ventricular assist device next week, said Allan Robinson, one of four co-founders […]
Medtronic (NYSE:MDT) announced Thursday that one of its new innovative medical devices — this time the world’s largest transcatheter aortic valve, part of its CoreValve line of heart valves — has been approved in Europe. The valve is 31 mm in size but can be delivered with the same system that works with smaller, 26 […]
Stem cell therapy developer Athersys (NASDAQ:ATHX) plans to begin phase 2 clinical trials of its MultiStem therapy for stroke and heart attack patients by the end of the year. Moving ahead with its stroke therapy is key for Athersys because that application represents its biggest market. CEO Gil Van Bokkelen pegged the potential stroke market […]
A Cleveland-area startup is developing an electromagnetic vibrating catheter and guidewire system that could give interventional cardiologists a better means of pushing through serious coronary artery blockages called chronic total occlusions. Mentor, Ohio-based VasoStar recently received a $1 million grant through Ohio’s Third Frontier technology acceleration program that the company plans to use to fund […]