May 22, 2015

HeartWare Recalls Heart Kit

Framingham, Mass.-based HeartWare has initiated a Class I recall of its ventricular assist system pump driveline splice kit because they fail to work properly when exposed to excessive force. The company is asking consumers to contact them with questions and concerns. View the recall notice at www.fdanews.com/05-18-15-HeartWareRecall.pdf.

Ecuador Drafts Reg on Surgical Gloves

Ecuador has issued a draft technical regulation establishing performance and safety requirements for single-use surgical and examination/procedure gloves. The measure would apply to both domestically manufactured and imported gloves marketed in the country. Comments are due Aug. 2, and the regulation is slated for adoption Aug. 4, with a Feb. 4, 2016, effective date. Read the draft, in Spanish, at www.fdanews.com/5-15-Ecuador-Gloves.pdf.

Siemens Reaches $6M Settlement

Siemens’ imaging division has agreed to pay $6 million to settle allegations that it overcharged the U.S. Department of Defense and Veterans Affairs Administration between 2002 and 2008. Prosecutors say the company didn’t offer DOD the best price on certain purchases and hiked prices for the VA for imaging devices that were converted to newer models. Siemens denied the allegations, but agreed to settle to avoid protracted litigation, according to the settlement agreement.

Kips Bay May Shut Down

Kips Bay Medical could be forced to shut down after a clinical trial on its sole product, the eSVS mesh for use in coronary artery bypass grafting surgery, failed to prove effective. The company reorganized in January, going from 13 to eight employees. In March, the devicemaker was able to raise private equity under the condition that the mesh clinical trial reached a specified benchmark in preliminary results released earlier this month. Of an initial 10 patients implanted with the device, seven displayed lower efficacy than those in the control arm at six-month’s follow-up. The FDA issued a nonapprovable letter in September 2011 for the eSVS mesh, requesting more information on the device before allowing a feasibility study. The agency approved the study in November 2012.

Medtronic Pacemaker Meets Safety Goals

The first 140 patients in a global trial of Medtronic’s Micra transcatheter pacing system met clinical safety and performance measures, the company says. The patients suffered from a wide range of conditions, including chronic obstructive pulmonary disease and pulmonary hypertension. Mean electrical pacing measurements at one- and three-month follow-ups came in at expected ranges for all subjects. The multinational trial will eventually enroll up to 780 patients. The device — which is the size of a large vitamin, or less than one-tenth the size of most pacemakers — won CE mark approval last month.