Stryker receives FDA clearance for OptaBlate® BVN Basivertebral Nerve Ablation System

Rhea-AI Summary

Stryker (NYSE:SYK) has received FDA 510(k) clearance for its OptaBlate basivertebral nerve ablation system (OptaBlate BVN), designed to treat chronic vertebrogenic low back pain. The system represents a minimally invasive solution that targets the basivertebral nerve for long-lasting pain relief. Key features include achieving a 1 cm lesion in 7 minutes, steerable curved introducer, microinfusion technology for hydration, and 10-gauge access tools. This addition expands Stryker's pain management portfolio, combining their expertise in radiofrequency ablation technology and vertebral access. The system will be showcased at the American Society of Pain & Neuroscience Annual Meeting in Miami, FL, July 17-20.

Positive

• FDA 510(k) clearance expands Stryker's product portfolio in the pain management market
• System offers minimally invasive alternative to surgery for chronic back pain patients
• Leverages company's existing expertise in radiofrequency ablation and vertebral access
• Addresses underserved market of chronic vertebrogenic lumbar pain patients

Negative

• None.

Insights

Medical Device Analyst

FDA clearance of Stryker's OptaBlate BVN system opens significant revenue opportunity in the underserved chronic back pain market.

Stryker's FDA clearance for the OptaBlate BVN system represents a strategic expansion of its pain management portfolio by targeting the basivertebral nerve for chronic vertebrogenic low back pain. This approval is particularly valuable as it leverages Stryker's existing core competencies in both radiofrequency ablation technology and vertebral access, creating synergies within their product ecosystem.

The technical specifications reveal impressive capabilities: the system creates a 1 cm lesion in just 7 minutes, features a steerable curved introducer for precision targeting, and employs microinfusion technology to maintain hydration and prevent complications like charring. The 10-gauge access tools balance minimal invasiveness with effective treatment delivery.

What makes this approval particularly significant is the large addressable market of patients suffering from chronic vertebrogenic lumbar pain who have exhausted conventional therapies like physical therapy and medications. As Dr. Khalil notes, this procedure offers a minimally invasive alternative that could potentially help patients avoid more aggressive surgical interventions.

From a competitive standpoint, Stryker positions this as addressing an "underserved population," suggesting they've identified a valuable market segment with limited existing solutions. The timing of this product introduction at the upcoming ASPN Annual Meeting in July provides an immediate commercialization pathway and visibility to key pain specialists who would be early adopters.

Stryker's first basivertebral nerve ablation system targets the basivertebral nerve to provide relief from chronic^* vertebrogenic low back pain.

PORTAGE, Mich., May 19, 2025 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) received 510(k) clearance from the U.S. Food and Drug Administration. OptaBlate BVNA is used in a targeted minimally invasive procedure providing long-lasting^† vertebrogenic pain relief¹. The addition of the OptaBlate BVN to Stryker's pain portfolio expands its advanced pain therapy solutions for patients and is an intersection of its two core competencies: radiofrequency ablation technology and vertebral access.

"We often see patients with chronic low back pain who have tried multiple treatments—physical therapy, injections, medications—without lasting relief," said Dr. Jad Khalil, Spine Surgeon at Michigan Orthopaedic Surgeons. "BVNA is a minimally invasive and innovative procedure that targets a key source of this pain, particularly in patients with specific MRI findings. Before BVNA, options for lasting relief were limited. For many, it offers meaningful improvement and can help avoid more aggressive treatments like surgery."

Key features of the system include:

• Achieves at least a 1 cm lesion in 7 minutes²
• Steerable, dynamic curved introducer for targeted performance²
• Microinfusion technology, which keeps the zone hydrated, reducing impedance errors and preventing charring²
• 10-gauge access tools

"We have a long history in radiofrequency ablation, and we're relentlessly committed to delivering groundbreaking approaches to protect and promote quality of life," said Kristen Berg, vice president and general manager of Stryker's Interventional Spine business. "Our legacy providing solutions to reduce pain now continues with OptaBlate BVN, addressing the underserved population suffering from chronic vertebrogenic lumbar pain."

Stryker's Interventional Spine business will introduce OptaBlate BVN as part of its pain portfolio at the American Society of Pain & Neuroscience (ASPN) Annual Meeting, July 17-20, in Miami, FL. (Booth #154).

For questions, please click here.

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside our customers around the world, we impact more than 150 million patients annually. More information is available at www.stryker.com.

Media contact
Beth Sizemore
Senior Director, Communications
beth.sizemore@stryker.com 

*Chronic low back pain of at least six months duration that has not responded to at least six months of conservative care
†The evidence shows patients treated with BVNA had sustained benefits in pain and function for up to 5 years 

References

1. Fischgrund JS, Rhyne A, Macadaeg K, Moore G, Kamrava E, Yeung C, Truumees E, Schaufele M, Yuan P, DePalma M, Anderson DG, Buxton D, Reynolds J, Sikorsky M. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25. PMID: 32451777.
2. Stryker data on file.

View original content to download multimedia:https://www.prnewswire.com/news-releases/stryker-receives-fda-clearance-for-optablate-bvn-basivertebral-nerve-ablation-system-302459050.html

SOURCE Stryker

FAQ

What is Stryker's OptaBlate BVN system and what FDA approval did it receive?

OptaBlate BVN is a basivertebral nerve ablation system that received FDA 510(k) clearance. It's designed for minimally invasive treatment of chronic vertebrogenic low back pain by targeting the basivertebral nerve.

What are the key features of Stryker's OptaBlate BVN system?

The system features a 1 cm lesion achievement in 7 minutes, steerable curved introducer, microinfusion technology for hydration, and 10-gauge access tools.

How does the OptaBlate BVN system benefit chronic back pain patients?

It provides a minimally invasive alternative to surgery, offering long-lasting pain relief for patients who haven't found success with traditional treatments like physical therapy, injections, and medications.

When will Stryker (SYK) introduce the OptaBlate BVN system to the market?

Stryker will introduce OptaBlate BVN at the American Society of Pain & Neuroscience Annual Meeting, taking place July 17-20 in Miami, FL.