FDA Clears Two New Stryker Products

Stryker Corp.’s has received 510(k) clearances from the U.S. Food and Drug Administration for two new products in its interventional spine portfolio. The Venom RF (radiofrequency) cannula and electrode combination is designed to provide a minimally invasive treatment for facet joint pain. The launch of the 11 g iVAS balloon system, which Stryker claims is one of the least invasive vertebral augmentation options available on the market, addresses the surgical trend of shifting toward less invasive treatment options.

The addition of these products is part of Stryker’s larger strategy of becoming a one-stop shop for minimally invasive spine solutions.

The Venom electrode addresses technical challenges that exist for the effective use of radiofrequency treatment for spinal pain. The Venom cannula and electrode features a “V” shaped active tip designed to increase the lesion volume and provide an optimized configuration to target lesion zones.

“The target for radiofrequency lesioning is not a point, it’s a volume,” said Aaron Calodney, M.D., of Texas Spine and Joint Hospital in Tyler. “It’s important to produce a lesion that fills the target zone.”

“Venom is not only smaller, but has the potential for less burning time,” said Paul Lynch, M.D., owner of Boost Medical and co-founder of Arizona Pain Specialists, both in Scottsdale. “On average, the 20-gauge Venom electrode and cannula combination created a lesion of 92 percent greater volume than the 20-gauge standard RF cannula, and the 18-gauge Venom cannula created a lesion of 76 percent greater volume than the 18-gauge standard RF cannula.”

Vertebral augmentation procedures require physicians to navigate their access cannulas through a small bridge of bone known as the pedicle, the anatomical formation that grants access to the vertebral body.  The 11 g iVAS balloon system has a 20 percent smaller cross-sectional area than a traditional 10 g system and a 47 percent smaller cross-sectional area than the original 8 g vertebral augmentation equipment. 

“In today’s day and age, if I was going to treat my mom and dad, I would want to use the least invasive cannula to give me an adequate fracture repair,” said Lynch. “The 11 g iVAS balloon system is just as efficacious (as previously available balloon systems) but less invasive, which is exciting.”

Stryker is a medical device company that focuses primarily on neurotechnology and orthopedic technology. The company is headquartered in Kalamazoo, Mich.,