One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.
Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.
Bellerophon Therapeutics spun out of private-equity-backed Ikaria to develop two programs, but now one of these has failed in its first major trial. It reported top-line results of a trial for its bioabsorbable cardiac matrix to prevent heart failure after a heart attack.
Academics at Vanderbilt University's Medical Engineering and Discovery Laboratory have added a wrist to a needle-based surgical robot that's already been 6 years in development. Now, the researchers are ready to put the system to the test in head and neck surgeries, with transnasal surgeries to remove tumors from the pituitary gland likely up first in the clinic.
Gynesonics has received $43 million from investors to support the clinical development of its Sonata System, which uses radiofrequency energy to ablate fibroids under intrauterine sonography guidance in a transcervical procedure that preserves the uterus.
Boston Scientific has started a study of its first resorbable, drug-eluting scaffold system to treat atherosclerotic coronary lesions. It incorporates aspects of the company's Synergy System, which has a resorbable polymer and everolimus drug-coating, that the device maker expects will be approved by the FDA during the fourth quarter.
Fractyl Laboratories has started a sizable clinical trial to test its noninvasive duodenal resurfacing technology as a treatment for insulin resistance in Type 2 diabetes patients. The news comes after the startup garnered a $40 million Series C round from investors including Mithril Capital Management last fall.
Startup Clinical Ink said that it's in the midst of a pilot clinical study that incorporates medical device data that's collected through a smartphone app with biopharma Novartis and contract research organization PPD. The trial incorporates medical device connectivity that's provided by Clinical Ink and powered by Qualcomm's 2net Mobile Platform.
The U.S. Food and Drug Administration issued an alert that patient deaths and other serious adverse events have occurred due to the off-label use of the Lariat Suture Delivery Device marketed by startup SentreHeart. It's approved to deliver sutures for soft tissue closure, but surgeons have been using it to close the left atrial appendage in order to prevent stroke in patients with irregular heart rhythm.
Intersect ENT has more than doubled its share price since an IPO last July. To help fuel its next leg of growth, the company has started pivotal testing for its latest bioabsorbable stent slated to go on the market in 2017 and raised $103 million in a follow-on offering.