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.

Abbott Laboratories has won the U.S. FDA’s nod for an iOS-compatible app that is designed to optimize care for people using the company’s neuromodulation devices to manage their chronic pain and movement disorders. The digital tool, which can be used on several Apple devices, is part of Abbott’s Neurosphere Digital Care connected care management platform, which launched in May.

The U.S. FDA has given its nod to Abbott Laboratories' next-generation Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The Gallant system pairs with Abbott's secure Mymerlinpulse, an iOS- and Android-compatible mobile smartphone app that aims to streamline communication between doctors and their patients.

Medtronic plc has won the U.S. FDA’s nod for the first deep brain stimulation (DBS) system that integrates Brainsense, the company’s technology to sense and record brain signals for more personalized treatment. The next-generation Percept PC DBS with Brainsense is approved to treat symptoms associated with Parkinson’s disease, essential tremor, dystonia, epilepsy and obsessive-compulsive disorder.

Mainstay Medical Holdings plc has won U.S. FDA approval for its Reactiv8 implantable neurostimulation device. The company is eyeing a commercial launch of the system in early 2021. The FDA approved Reactiv8 as an aid in managing intractable chronic low back pain associated with multifidus muscle dysfunction in adults who have failed therapy and are not candidates for spine surgery.

Wayne, Pa.-based Intact Vascular Inc. has secured U.S. FDA approval for the first peripheral vascular implant to repair below-the-knee (BTK) post-angioplasty dissections. The company expects to begin shipping units of the Tack endovascular system (4F) in about two weeks.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.

Aegea Medical Inc., of Menlo Park, Calif., has received U.S. FDA approval for its next-generation Mara water vapor ablation system, the only endometrial ablation treatment that uses vapor to treat heavy menstrual bleeding. The first commercial procedure was performed by Kirk Brody, an obstetrician-gynecologist in Chattanooga, Tenn.

The U.S. has granted final approval to Microvention Inc., a subsidiary of Terumo Corp. based in Aliso Viejo, Calif., for its Flow Redirection Endoluminal Device (FRED) for the treatment of brain aneurysms. The flow diverter – Microvention’s third PMA approval in less than two years – is the first in the U.S. to utilize a self-expanding, braided nitinol mesh to aid in rerouting blood flow away from the weakened area and promote occlusion.