Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 12 August to Friday 16 August.
Cardiology
FDA approval—Evolut R, Evolut PRO (Medtronic); Sapien 3, Sapien 3 Ultra (Edwards Lifesciences)
The FDA has approved Evolut R, Evolut PRO (Medtronic), Sapien 3 and Sapien 3 (Edwards Lifesciences) for the management of low-risk patients with severe aortic stenosis. The approval follows the publication—in the New England Journal of Medicine—of two studies that showed positive results with these devices in low-risk patients. Prior to the FDA approval, the devices were only approved for intermediate-risk and high-risk patients.
FDA approval—Barostim Neo system (CVRx)
The FDA has approved the Barostim Neo system (CVRx) for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronisation therapy. A press release reports that, previously, FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.
FDA Breakthrough Device Designation— Interarterial shunt (V-Wave)
V-Wave has announced that the FDA has just granted the company a Breakthrough Device Designation for its interatrial shunt for heart failure. V-Wave’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomised, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline directed medical and device therapies.
Neurology
FDA approval—ImageReady MRI labelling, Vercise Gevia DBS (Boston Scientific)
Boston Scientific has announced the FDA approval of its ImageReady MRI labelling for the Vercise Gevia deep brain stimulation (DBS) system to be used in a full-body magnetic resonance imaging (MRI) environment. This system, with the Vercise Cartesia directional lead, is designed to treat the symptoms of Parkinson’s disease by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.
Spine
FDA approval—The Tether (Zimmer Biomet)
Zimmer Biomet has announced FDA approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. A press release reports that The Tether uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten the spine, while the inside of the curve is left free to grow. This growth modulation approach now offers select, well-indicated patients an option to achieve a straighter spine, without the limitations of spinal fusion. Additionally, unlike fusion metallic rods, The Tether is positioned using an endoscopic minimally invasive approach through a few small openings between the ribs.
Vascular
FDA Breakthrough Device Designation—Ascyrus Medical Dissection Stent (Ascyrus Medical)
Ascyrus Medical has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. A press release reports that this designation serves as validation of the clinical importance of the AMDS and represents a significant milestone in the continued advancement of the technology globally. Ascyrus Medical conducted the largest prospective, monitored type A dissection trial (DARTS) with patients enrolled in Canada and Germany. The results have shown a significant reduction in mortality and re-interventions along with effective malperfusion management, without any device related adverse events.
FDA Breakthrough Device Designation—MagicTouch peripheral balloon (Concept Medical)
Concept Medical has been granted Breakthrough Device Designation from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) device—a sirolimus drug-coated balloon catheter—for the treatment of below-the-knee lesions. Earlier this year, on 30 April 2019, Concept Medical received its first Breakthrough Device for its MagicTouch coronary balloon for the treatment of Coronary Artery Disease in patients with in-stent restenosis.
