The Kalamazoo, Mich.-based device maker won FDA clearance for its Venom RF cannula and electrode combo device and for its 11g iVAS Balloon System.
Venom RF is a spine pain treatment device that combines a cannula (tube) and electrode component to create a "V" shaped tip that allows physicians to target lesion zones. The iVAS is a balloon with a small surface that squeezes through a small bridge of bone to correct spine fractures.
A company statement called the 2 new regulatory wins evidence of the medical device giant’s dominance in the market for minimally invasive spine devices. Earlier this year Stryker shelled out $764 million for Trauson, a Chinese medical device company that makes spinal and trauma care products.
Stryker Corp. recently landed in hot water for its other spine product, the Oasys Midline Occipital Plate, which was the subject of an Australian health department alert after regulators learned that the devices may break following surgery, possibly causing patient harm and requiring revision surgery.