Author Archives: Andrea Gonzalez

Biostable Science & Engineering scores FDA nod for aortic valve repair device

By Omar Ford, Staff Writer Biostable Science & Engineering Inc. received FDA clearance for its Haart 300 product, an annuloplasty device designed for aortic valve repair. The Austin, Texas-based company said it will launch the device in select heart centers…

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Trial serves as ‘GENESIS’ of Origin’s path in obtaining approval for DFU therapy

By Omar Ford, Staff Writer Treatment has begun on the first patients in Origin Inc.‘s U.S. dose-ranging GENESIS trial. The Princeton, N.J.-based company has developed a technology to produce and deliver plasma-generated nitric oxide for the treatment of chronic diabetic…

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Studies tout iFR as alternative to FFR for deferral of coronary artery disease

By Mark McCarty, Regulatory Editor WASHINGTON – Payers are quite interested in technologies that determine whether a patient really needs an expensive treatment, but fractional flow reserve (FFR) might have to take a back seat to instantaneous wave-free ratio (iFR)…

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Alarmism falters despite an FDA MACE alert for Abbott Laboratories’ GT1 scaffold

By Mark McCarty, Regulatory Editor WASHINGTON – The FDA broke an embargoed release of data for Abbott Laboratories‘ Absorb GT1 scaffold, advising clinicians that the rates of major adverse cardiac events in a large study were higher than seen with…

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Surtavi: Medtronic’s Corevalve ready for patients at intermediate risk

By Mark McCarty, Regulatory Editor The TAVR wars heated significantly at the annual meeting of the American College of Cardiology, where a new set of data for the Corevalve series of devices demonstrated that the Dublin-based Medtronic plc offering beats…

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Renalguard raises $14.5M for closed-loop hydration during cath procedures

By Stacy Lawrence, Staff Writer Corporate restart Renalguard Solutions Inc. has raised a $14.5 million series A round to get its device through an ongoing U.S. pivotal trial to protect against contrast-induced acute kidney injury and onto the market. Renalguard…

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FDA approves expanded indication for Medtronic transcatheter pulmonary valve

By Stacy Lawrence, Staff Writer Medtronic plc has received the first FDA approval for a transcatheter pulmonary valve to treat patients whose bioprosthetic pulmonary heart valves have failed. For these congenital heart disease patients, many of whom undergo repeat open…

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EBG petitions FDA to limit term of review of combo product appeals

By Mark McCarty, Regulatory Editor The regulatory law firm of Epstein Becker Green (EBG) has petitioned the FDA to set a limit to the number of days the agency can take to review petitions regarding combo product designations, stating that…

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FDA nominee Gottlieb’s industry ties, regulatory approach a concern for critics

By Mari Serebrov, Regulatory Editor Scott Gottlieb’s nomination as the next FDA commissioner is garnering support from industry, but it’s generating some opposition from other quarters. A few lawmakers and Public Citizen, a watchdog group, were among the first to…

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Medtronic tries, again, with drug-coated balloons for below-the-knee PAD

By Stacy Lawrence, Staff Writer Medtronic plc has had a couple of failed trials in below-the-knee peripheral arterial disease (PAD) with its drug-coated balloon (DCB) technology. Now, the Dublin, Ireland-based med-tech giant is giving it another shot with a small,…

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