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MultiGen 2 Radiofrequency Generator Gains FDA Clearance

July 17, 2017
This second generation device promises to improve efficacy with greater control and improved accuracy in radiofrequency ablation procedures for facet joint pain, delivering less pain for 1 year.

With Brad Wallace and Aaron Calodney, MD

A second generation minimally invasive device, the MultiGen 2 Radiofrequency (RF) Generator, designed for more effective low back pain relief, received 510(k) clearance from the Food and Drug Administration, based on a statement issued by the manufacturer,1 Stryker Corporation, Kalamazoo, Michigan.

The product will be introduced to practitioners as “an advanced method of providing less pain for up to 1 year,”1 during the Spine Intervention Society 25th annual meeting, July 19 to 22, in San Francisco, California.

in managing chronic low back pain, use of nonpharmacologic treatments is recommended in the American College of Physicians guidelines for low back pain.2

"The MultiGen 2 RF Generator [will provide] physicians with control and confidence, making radiofrequency ablation more efficient and reliable than ever before," according to Brad Wallace, brand manager for Stryker.

Second generation radiofrequncy generator gains FDA clearance for facet joint pain.

An estimated 70 million Americans may experience facet joint pain during their lifetime,3 which is a primary source of persistent low back pain. In fact, research on low back pain suggests that a majority of patients can be expected to experience involvement in their fact joints.6,7 Typically, facet joint pain develops following an injury, due to arthritis, or as a result of degenerative disc disease.

Opportunity for Sustained Pain Relief

Radiofrequency ablation is usually recommended to patients who having been suffering from chronic low back pain and for which the standard treatments (eg, anti-inflammatories, physical therapy, chiropractics) no longer provided adequate relief.5

Supported by several studies,6,7 the majority of patients have reported a significant reduction in both the severity and frequency of low back pain following RF ablation.1

In unveiling this 2nd generation device, the manufacturer described its ability to deliver “an electrical current at twice the industry standard, which will afford physicians greater control and reliability when performing RF ablation,”1 said Mr. Wallace.

The manufacturer added that the features in this 2nd generation product1 promise to:

  • Reach target temperature faster
  • Lower error rate
  • Increase efficiency

As with many spinal injections, radiofrequency neurotomy is best performed under fluoroscopy (x-ray) for guidance in properly targeting and placing the needle to prevent nerve or tissue injury.

A Clinical Perspective

Having had the opportunity to trial the MultiGen 2 Radiofrequency Generator, I found that it ramps up to temperature quickly and has an outstanding user interface, said Aaron Calodney, MD, a board certified anesthesiologist, specializing in interventional pain management with an emphasis on conditions of the spine. 

 "When performing the procedure, I can create four lesions, 2 simultaneous bipolar lesions, or  a bipolar lesion and 2 individual thermal lesions—whatever I want," Dr. Calodney told Practical Pain Management, "The MultiGen 2 RF Generator has allowed me to fine-tune the procedure according to my personal preferences and, most importantly, patient need."

Dr. Calodney co-founded Precision Spine Care, an integrated spine and pain center in Tyler, Texas, and is the past president of the American Society of Interventional Pain Physicians (ASIPP), where he currently serves on the Board of Directors.

Last updated on: July 19, 2017
Continue Reading:
American College of Physicians Releases New Guidelines for Low Back Pain
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