Stryker product earns FDA approval
Stryker has received FDA clearance for a new medical device.
Kalamazoo-based Stryker said last week its MultiGen 2 Radiofrequency Generator received FDA 510(k) clearance, which declares the medical device safe and "substantially equivalent" to a legally marketed device in the industry.
The MultiGen 2 is designed to provide physicians with the "efficiency, control and reliability" needed when performing RF ablation, or RFA, a process that sends a radio-wave-induced electrical current to a specific area of nerve tissue to reduce pain.
RFA is used to treat patients with facet joint pain, which happens when the facet joints, located on the back of the spinal column, suffer injury, stiffen, loosen or become locked from a sudden irregular movement.
Seventy-million Americans experience lower back pain at any given time, according to Stryker.
"The next-generation of radiofrequency ablation has arrived," said Brad Wallace, brand manager, Stryker.
Wallaced added that the device for RFA procedures provides physicians with "confidence."
Strykder said the MultiGen 2 RF Generator achieves target temperature faster, with fewer errors, for increased reliability and efficiency over the previous model.
Physicians can start a procedure with the push of a button and resolve errors without stopping the procedure, maximizing time and schedules.
Procedures are customizable based on patient needs and physician preferences through flexible stimulation controls.
Stryker is a medical technology company that makes a variety of medical equipment and devices designed to “improve patient and hospital outcomes,” and it also offers related services.
The company is active in more than 100 countries around the world.