FDA Approvals

Departments - Regulatory

Boston Scientific's Lotus Edge Aortic Valve System; Orchestra BioMed’s Virtue Sirolimus-Eluting Balloon (SEB); BAROnova’s TransPyloric Shuttle (TPS) device


Boston Scientific Corp. received approval for the Lotus Edge Aortic Valve System transcatheter aortic valve replacement (TAVR) technology (above), delivered via a minimally-invasive procedure for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.

Orchestra BioMed’s Virtue Sirolimus-Eluting Balloon (SEB) for the treatment of coronary in-stent restenosis (ISR) secured breakthrough device designation from the FDA. Virtue SEB is a drug/device combination product delivering sustained-release bioabsorbable nanoparticle-encapsulated Sirolimus for preventing restenosis directly to the artery during balloon angioplasty, without the need for a coating.

BAROnova’s TransPyloric Shuttle (TPS) device, a non-surgical weight loss solution for individuals with a body mass index (BMI) of 30kg/m2 to 40kg/m2 received approval for up to 12 months of treatment. The TPS device is delivered and retrieved endoscopically, and it relies on its mechanical structure to maintain its shape to remain in the stomach. It is 5.6cm in diameter – the size of a small peach.

Surmodics Xtreme braid-reinforced Sublime sheath, designed to resist kinks, offers maximum strength, and retain a low profile, received 510(k) status. The guide sheath is Serene hydrophilic coated for a lubricious surface. Preloaded with a dilator, it has a hemostasis valve with side arm for flushing. The dilators are available with 0.018” and 0.035” guide wire compatibility.

Grant Thornton launches EU MDR, IVDR tools

SmartMDR and SmartIVDR offer cloud-based assessment and project management for compliance with heightened requirements of the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The tools establish a structured, repeatable way for companies to conduct and capture technical and quality document assessment data – and to estimate costs and levels of effort to remediate gaps identified in product compliance assessments.

Transformations in spinal surgery

The “Early Clinical Outcomes Comparing Porous PEEK, Smooth PEEK, and Structural Allograft Interbody Devices for Anterior Cervical Discectomy and Fusion,” study concludes that the NuVasive Cohere Porous polyetheretherketone (PEEK) implant demonstrates a benefit in promoting improved early outcomes over structural allograft and smooth PEEK in anterior cervical discectomy and fusion (ACDF) procedures.

In the study, 167 patients presenting with degenerative cervical disc disease underwent ACDF using Cohere Porous PEEK, structural allograft or smooth PEEK in the interbody space. Patients receiving Cohere exhibited significant clinical improvements relative to preoperative (pre-op) scores, better outcomes than alternative treatments as early as six weeks, and sustained improvements relative to other treatments through 12-months post-op.