Regulatory news, insights - September 2025

510(k) clearance for nerve ablation system

PHOTO COURTESY OF STRYKER

Stryker has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its OptaBlate basivertebral nerve ablation system (BVN), which is used in a targeted minimally invasive procedure for long-lasting vertebrogenic pain relief. The OptaBlate BVN offers new options to patients with lower back pain who have tried multiple treatments such as physical therapy, injections, and medications without lasting relief.

Key features of the OptaBlate BVN:

• Achieves at least a 1cm lesion in 7 minutes
• Steerable, dynamic curved introducer for targeted performance
• Microinfusion technology, which keeps the zone hydrated, reducing impedance errors and preventing charring
• 10-gauge access tools

The OptaBlate BVN combines two of Stryker’s core competencies: radiofrequency ablation technology and vertebral access.

STRYKER
https://www.stryker.com

FDA approval for mitral valve disease treatment

The U.S. Food and Drug Administration (FDA) has approved Abbott’s Tendyne transcatheter mitral valve replacement (TMVR) system to treat people with mitral valve disease. The therapy is available for patients whose mitral valves aren’t functioning properly due to severe mitral annular calcification (MAC), a buildup of calcium within the annulus, a ring-like structure supporting the mitral valve.

The self-expanding Tendyne valve is delivered through a small incision in the chest and then advanced into the heart to replace the mitral valve. The valve is fully repositionable and retrievable during implantation, offering a minimally invasive alternative for patients who are too high-risk for open heart surgery.

ABBOTT
https://www.abbott.com