Stryker's MultiGen® 2 Radiofrequency Generator Receives FDA 510(k) Clearance

KALAMAZOO, Mich., July 11, 2017 /PRNewswire/ -- Stryker announced today that it has received FDA 510(k) clearance for its MultiGen 2 RF Generator. This product provides physicians with the efficiency, control and reliability they need when performing radiofrequency ablation, a minimally invasive procedure that can provide lasting relief to those suffering from facet joint pain.¹ The MultiGen 2 RF Generator will debut at the Spine Intervention Society's 25^th annual meeting, July 19-22, in San Francisco.

Seventy million Americans experience low back pain at any given time.² Facet joint pain is a well-recognized source of pain in patients with persistent back pain.^3,4,5 Multiple clinical studies show that for the majority of patients, radiofrequency ablation significantly reduces pain severity and frequency for one year.^3,6

"The next generation of radiofrequency ablation has arrived," said Brad Wallace, brand manager for Stryker. "The MultiGen 2 RF Generator provides physicians with control and confidence, making radiofrequency ablation more efficient and reliable than ever before."

Engineered with double the industry standard for power, the MultiGen 2 Generator achieves target temperature faster, with fewer errors, for increased reliability and efficiency. Physicians can start a procedure with the push of a single button, create strip lesions without removing electrodes and resolve errors without stopping the procedure, maximizing time and schedules. Procedures are customizable based on patient needs and physician preferences with flexible stimulation controls.

The MultiGen 2 RF Generator and Venom Cannula and Electrode System make up Stryker's Performance Platform. Physicians can confidently create the industry's largest, least-invasive lesions in the shortest amount of time.⁷ Together, the Performance Platform delivers reliability, efficiency and ultimate control. More information about Stryker's new MultiGen 2 RF Generator and the Performance Platform is available at www.strykerivs.com/rfa.

About Stryker
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world. Please contact us for more information at www.stryker.com.

¹ International Spine Intervention Society. Practice Guidelines for Spinal Diagnostic and Treatment Procedures. Percuteneous radiofrequency lumbar medial branch neurotomy. pp188-218
² Estimate taken from the National Center for Health Statistics. Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities. Hyattsville, MD. 2016 and American FactFinder, United States Census Bureau. (https://factfinder.census.gov). Accessed June 23, 2017
³ Boswell MV, Colson JD, Spillane WF. Therapeutic facet joint interventions in chronic spinal pain: a systematic review of effectiveness and complications. Pain Physician 2005 Jan;8(1):101-14
⁴ Sehgal N, Shah RV, McKenzie-Brown A, Everett CR. Diagnostic utility of facet (zygapophysial) joint injections in chronic spinal pain: a systematic review of evidence. Pain Physician 2005 Apr;8(2):211-24
⁵ SpineUniverse.com. "Facet Rhizotomy."Steven Richeimer, MD. www.spineuniverse.com/displayarticle.php/article200.html. Accessed October 13, 2008
⁶ Dreyfuss P, Halbrook B, Pauza K, Joshia A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine. 2000 May 15;25(10):1270-7
⁷ Based on 18-gauge Venom Cannula and Electrode System

SOURCE Stryker