Of all the things that irritate physicians about health insurance, prior authorization might be at the top of the list. That didn’t stop the U.S. Centers for Medicare & Medicaid Service (CMS) from imposing a prior authorization requirement for the implant of spinal stimulators and for cervical fusion with disc removal in the calendar year 2021 Medicare outpatient prospective payment system, however.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service.
Stryker Corp. has launched its Surpass Evolve flow diverter following an earlier U.S. FDA approval. According to the company, it is the first 64-wire cobalt chromium flow diverter in the U.S. designed to redirect blood flow and promote aneurysm healing. Ajay Wakhloo, the first physician to complete a commercial case in the U.S., noted that the offering builds on Stryker’s Surpass Streamline. “By increasing the braid angle, the novel 64-wire device delivers excellent flow diversion and a highly flexible implant for enhanced vessel wall contact. The higher mesh density of Surpass Evolve vs. traditional 48-wire flow diverters may lead to faster aneurysm occlusion for patients," Wakhloo said.
The U.S. FDA expanded the indications for Stryker Corp.’s Neuroform Atlas stent system to include use in the posterior circulation or back of the brain, making the device the only adjunctive stent approved for aneurysms in this challenging location. The Kalamazoo, Mich.-based company’s intracranial coil-assist stent gained its initial indication for the more common aneurysms in the anterior circulation of the neurovasculature in May 2019.
Despite a drop off in elective procedures due to the COVID-19 pandemic, Stryker Corp., of Kalamazoo, Mich., unveiled first-quarter results that came in better than analysts had presumed. BTIG’s Ryan Zimmerman noted that, unlike other companies, Stryker did not pre-announce preliminary revenue. And while investors were concerned that the company would be adversely affected by the slump in elective procedures, "the diversity of the portfolio helped to offset procedure declines in late March.”
Stryker Corp., of Kalamazoo, Mich., saw strength in the fourth quarter, with Mako experiencing good uptake in total knee arthroplasty. Katherine Owen, Stryker’s vice president of strategy & investor relations, said Mako demand was driven by the benefits of its robotic technology, multiple applications and the ability to do cementless knee.
Stryker Corp. is making another big buy, this time picking up Wright Medical Group NV, of Amsterdam, for a total enterprise value of about $5.4 billion. The deal is expected to close in the second half of 2020, and its value exceeds Stryker's previous large deal – that of Leesburg, Va.-based K2m Group Holdings Inc. in 2018 for $1.4 billion.
BOSTON – The Advanced Medical Technology Association (Advamed) opened its annual conference here in the capital of the Bay State with an emphasis on several policy points, including greater diversity and inclusion in the med-tech industry. Advamed board chairman Kevin Lobo said the device industry lags behind other industries in this regard, adding that device makers need to recognize that workforce diversity is "the key to innovation, the key to business success."
Stryker Corp., of Kalamazoo, Mich., is continuing its string of buys, this time scooping up Shirley, Mass.-based Mobius Imaging LLC, which focuses on point-of-care imaging technology, and its sister company, Cardan Robotics. In an all-cash transaction, Stryker will pay about $370 million up front and up to $130 million of contingent payments associated with development and commercial milestones.
