Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
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5. SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage.
Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA approved an expansion of the study, which can now enroll another 500 patients after an independent data monitoring committee reviewed the data against preset safety and performance criteria, Redwood City, Calif.-based SentreHeart said. Read more
4. Medovex wins CE Mark for DenerveX spinal denervation system
Medical technology portfolio company Medovex said today it won CE Mark approval in the European Union for its DenerveX spinal denervation treatment system designed to treat facet joint syndrome.
The DenerveX system uses a slowly rotating burr to remove targeted facet joint synovial membrane and radiofrequency ablation technology to destroy tissue and denude any residual nervous and synovial membrane on the joint, effectively removing sensory tissue from it, the Atlanta-based company said. Read more
3. Earlens closes $118m in mixed debt and equity round
Earlens said today it closed a total of $118 million in funding, with $73 million coming from an offering of Series C preferred stock and $45 from a structured debt facility with CRG LP.
The Earlens device, which won 510(k) clearance from the FDA in October 2015, uses a laser diode attached to a behind-the-ear audio processor to transmit sound to the receiver against the patient’s eardrum, to directly contact the patient’s eardrum and use it as a speaker, the Menlo Park, Calif.-based company said. Read more
2. NovoSource auction set for June 28
Orthopedic device developer NovoSource is headed to the auction block later this month, with the company’s assets to be sold off to pay a creditor.
The Dayton, Ohio-based medical device maker’s primary products were the NovoKnee total knee system and the NovoHip total hip system. In 2014 NovoSource defaulted on a loan from Rhododendron Holdings; the Court of Common Pleas of Montgomery County, Ohio, later ordered NovoSource to pony up more than $3.3 million to satisfy the debt. Read more
1. Claret Medical wins de novo FDA nod for Sentinel TAVR filter
Claret Medical said today that the FDA granted de novo clearance for its Sentinel device, which is designed to trap blood clots before they reach the brain during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. Although the device met its primary safety endpoint in a pivotal study (major adverse cardiac and cerebrovascular events at 30 days), it missed the primary efficacy endpoint of reduction in median new lesion volume in protected territories. In February an FDA advisory panel recommended approval for Sentinel, despite the efficacy question. Read more
