Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. St. Jude Medical launches post-approval Nanostim trial in Europe
St. Jude Medical said it’s enrolled the 1st patients in a post-approval trial of the Nanostim leadless pacemaker it acquired in October 2013.
The device won CE Mark approval in the European Union shortly before St. Jude exercised the exclusive buyout option it acquired in a 2011 investment in Nanostim. The Nanostim pacemaker is designed to be placed inside the heart of a cardiac patient in a percutaneous, catheter-based procedure. The devices are leadless, and therefore aren’t connected to the heart muscle via wires, a modification over previous models that the company touts as major safety improvement. Read more
2. Thoratec updates HeartMate II controller warning
Thoratec issued an update about a problem with its HeartMate II left ventricular assist device involved in 8 serious injuries or deaths.
Pleasanton, Calif.-based Thoratec said the problem, stemming from “[f]ailure to completely connect the driveline during the process of exchanging pocket system controllers,” is riskier for patients who started out with an older controller model and then attempted to upgrade to the newer pocket controller. Read more
1. InVivo Therapeutics sues ex-CEO Reynolds
InVivo Therapeutics said it’s suing former CEO Frank Reynolds, who stepped down last year citing health reasons, alleging that he ran up $500,000 worth of “personal and/or exorbitant expenses.”
Cambridge, Mass.-based InVivo said the lawsuit, filed in November 2013 in a Massachusetts state court, accuses Reynolds of “breaches of fiduciary duties, breach of contract, conversion, misappropriation of corporate assets, unjust enrichment, corporate waste.” Read more
