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 this summer. The company has had CE mark for the Haart 300 since March 2016. (See Medical Device Daily, March 9, 2016.) Heart valve repair is a procedure to repair native valve function instead of replacing it with a mechanical or biological replacement device. Valve repair may be more durable than biological valve replacement and avoids the complications associated with...

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 foot ulcers (DFU). Origin, which was formed in 2010 and was formerly called Advanced Plasma Therapies Inc., has developed a device with a hand-held, computer-guided system that generates nitric oxide from ambient room air within a defined plasma stream. From there, nitric oxide is generated and targeted toward the patients wound for about six to 12 minutes. "From an external...

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) for determining the need to revascularize the coronary arteries, according to two presentations at ACC 2017. Among the companies whose fortunes might be affected by any conclusions drawn from these studies is Heartflow, which reported at the 2016 edition of the American College of Cardiology annual meeting that it had wrapped up a study intended to nudge payers off the...

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 the comparator, but leading cardiologists at ACC 2017 were nonetheless unwilling to recommend that clinicians abandon the device. The FDA's safety alert preceded the embargo placed on the news from the Absorb III study – sponsored by the Abbott Park, Ill.-based company – by nearly 50 minutes, but contained no information that was not included in the presentation by Stephen...

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 surgical aortic valve replacement on several scores for intermediate-risk patients, a population already served by a TAVR offering from Edwards Lifesciences Corp. of Irvine, Calif. The 17th annual scientific sessions held by the American College of Cardiology commenced with the usual late-breaking clinical trial data releases, with the data from Surtavi serving as the premier device study presented on day...

The news at ACC 2017 has varied by product type, including TAVR devices, coronary artery stents and imaging modalities, As usual, there are potential and verifiable winners and losers, and in some cases, companies playing catch-up with the competition in an effort to take the lead, but this meeting is never boring. FDA says ‘what embargo?’ In one of the more interesting stories at ACC 2017, the FDA broke an embargo regarding 25-month data for the Absorb GT1 coronary artery scaffold by Abbott Vascular. The agency advised clinicians of the...

The FDA issued a Medwatch alert on March 18, regarding the rate of major adverse cardiac events for the Absorb GT1 scaffold by Abbott Vascular, breaking an embargo placed on the news at the American College of Cardiology annual meeting. The agency noted that the two-year data from the Absorb III study demonstrated an adverse event rate of 11 percent for the composite endpoint of cardiac death, heart attack or revascularization, a substantially higher rate than seen in the comparator arm of the study, which used the company’s Xience drug-eluting stent, which demonstrated a rate of 7.9 percent for this...

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 is designed to measure patient urine output in real-time and then to match that amount to hydration introduced during catheterization procedures. The Milford, Mass.-based company aims to have pivotal data in early 2018, which could be followed later next year by a PMA approval from the FDA. The financing will also go to support development of the device in additional...

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 heart surgeries as children and into adulthood, this validates the use of the Melody Transcatheter Pulmonary Valve (TPV) to avoid additional surgical procedures. BEYOND OFF-LABEL USE The Melody TPV has long been used off-label in this indication, but a retrospective study underlying the approval found that it's effective even in pediatric and adult patients with a smaller valve. It is...

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 as matters stand, the agency is "unaccountable for egregious delays in decision-making." The combination products dilemma has roiled relations between the FDA and regulated industries for some time, and the EBG petition, filed on behalf of the Combination Products Coalition, highlights yet another source of tension. Most of the controversy up to now has revolved around the process by which...