October 16, 2015

St. Jude Scores CE Mark for LVAS

St. Jude Medical has received the CE mark for its HeartMate 3 left ventricular assist system. St. Jude acquired the system after wrapping its purchase of Thoratec earlier this month. The system offers a cardiac support option for advanced heart failure patients awaiting transplantation, aren’t candidates for heart transplantation or are recovering from a heart attack. Receipt of the CE mark followed a clinical trial showing the HeartMate 3 LVAS met its primary endpoint of 92 percent survival at six months. HeartMate 3 is being evaluated in an IDE trial in the U.S.

Lumenis, XIO Wrap Up Merger

Israel’s Lumenis, which makes energy-based solutions for surgical, ophthalmologic and aesthetic applications, last week completed its merger with an affiliate of the Hong Kong investment firm XIO Group. Lumenis shareholders will receive $14 per share in cash. The two announced in June that XIO would buy Lumenis in a deal worth about $510 million. Lumenis specializes in laser-, intense pulsed light- and radio frequency-based technologies.

Mayo Clinic Wins Grant for Seizure Devices

The National Institutes of Health has awarded the Mayo Clinic a five-year, $6.8 million grant to develop devices to track and treat abnormal brain activity in people with epilepsy. The goal of the research is to develop an implant that can monitor brain activity to predict and prevent seizures. The grant is part of President Barack Obama’s BRAIN Initiative focused on disorders such as Alzheimer’s and epilepsy.

Recall of Cook Catheters Expanded

Cook Medical has initiated a voluntary recall for select sizes of Beacon tip angiographic catheters, an expansion of the voluntary lot-specific recall issued July 2. The recall covers specific versions of the Torcon NB Advantage Beacontip catheters, Royal Flush Plus Beacon tip high-flow catheters, Slip-Cath Beacon tip hydrophilic catheters and Shuttle Select Slip-Cath catheters. There have been 42 medical device reports concerning the Beacon tip angiographic catheters regarding tip splitting or separation, which has the potential to lead to loss of device function.

Groups Focus on Saudi Arabia, Kuwait

From April 23 to 28, the U.S. Department of Commerce and International Trade Administration are expected to lead a Healthcare Technology & Hospital Information Services Trade Mission to Saudi Arabia and Kuwait. The mission, which is supported by the U.S. Chamber of Commerce and the Saudi-American Healthcare Forum, will be geared toward U.S. companies and international hospital groups. Specifically, those that provide hospital operation and management services, information systems and eHealth solutions are encouraged to join. The ultimate goal is to help U.S. firms doing business in those countries to expand their footprint. To read the Federal Register announcement, visit www.fdanews.com/101915-Saudi-Kuwait.pdf.