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Stryker Interventional Spine (SYK) Grabs FDA OK for 2 Additional Products


8/7/2013 8:57:48 AM

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Stryker Interventional Spine Launches Two New Products to Expanding Portfolio: the Venom™ Cannula and Electrode Combination and 11g iVAS® Balloon System

KALAMAZOO, Mich., Aug. 7, 2013 /PRNewswire/ -- Stryker Interventional Spine announced the clearance of 510(k)s for two additional products to its portfolio. Venom RF Cannula and Venom Electrode are designed to provide an effective and minimally invasive treatment for facet joint pain. The launch of the 11g iVAS Balloon System, one of the least invasive vertebral augmentation options available on the market, addresses the surgical trend of shifting toward less invasive treatment options.

The additions of these products enhance Stryker's position as being a single source for minimally invasive spine solutions.

Venom RF Cannula and Electrode

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" shape active tip, which increases the lesion volume and provides an optimized configuration to target lesion zones. "The target for radiofrequency lesioning is not a point, it's a volume. It's important to produce a lesion that fills the target zone," says Dr. Aaron Calodney*, MD, Texas Spine and Joint.

"Venom is not only smaller, but has the potential for less burning time," says Dr. Paul Lynch*, MD, owner of Boost Medical and co-founder of Arizona Pain Specialists. On average, the 20-gauge Venom electrode and cannula combination created a lesion of 92% greater volume than the 20-gauge standard RF cannula, and the 18-gauge Venom cannula created a lesion of 76% greater volume than the 18-gauge standard RF cannula[i].

11g iVAS Balloon System

In vertebral augmentation procedures, physicians must skillfully 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 11g iVAS Balloon System has a 20% smaller cross-sectional area than a traditional 10g system and a 47% smaller cross-sectional area than the original 8g 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. The 11g iVAS balloon system is just as efficacious (as previously available balloon systems) but less invasive, which is exciting," says Dr. Paul Lynch, MD.

Physicians presented with the concept of a smaller vertebral augmentation system reacted with excitement and optimism for future compression fracture treatments. Dr. Wayne Olan*, Director of Minimally Invasive Neurosurgery at George Washington University Medical Center in Washington, DC, says, "With the release of the 11g iVAS Balloon System, a less invasive option is now available that affords physicians the opportunity to treat the same fractures that they currently see and opens the possibility of treating more challenging fractures."

About Stryker

Stryker Corporation is one of the world's leading medical technology companies that has a broadly based range of products in orthopedics and a significant presence in other medical specialties. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. Our Interventional Spine business manufactures minimally invasive solutions for relieving chronic back pain. Developed with respectful medical professionals, Stryker offers a wide range of innovative products for spinal procedures and pain management treatments that reduce patient pain, shortens recovery time and improve quality of life. For more information about our Interventional Spine business, please visit www.StrykerIVS.com.

[i] Effect of the Stryker Venom Cannula and Venom Electrode combination on Lesion Size and Anesthesia Delivery During Radiofrequency Ablation Stryker Instruments, 4100 East Milham Avenue, Kalamazoo, Michigan 49001.

* Drs. Lynch, Calodney and Olan have a consulting relationship with Stryker Instruments.

1000-025-252 Rev None

SOURCE Stryker Interventional Spine



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