SafeWire has received 510(k) clearance from the U.S. Food and Drug Administration to market its Y-Wire 2 orthopedic guidewire.
Here are five things to know about the company and the device:
1. The Y-Wire 2 is a patented orthopedic guidewire with a distinctive split tip that is designed to prevent inadvertent advancement of the wire through bone. "The Y-Wire 2 provides a solution to an ongoing issue in minimally invasive spine surgery. More importantly, it may also facilitate a return to bi-cortical fixation in the sacrum. Bi-cortical fixation in the sacrum has been the standard in open spinal surgery, but its adoption in minimally invasive surgery has been hampered by the issue of guidewire advancement," said Joseph Zavatsky, MD, of Ochsner Medical Center in New Orleans.
2. The Y-Wire 2 was designed for compatibility with a wide variety of delivery systems such as fluoroscopy, robotics and image guidance.
3. SafeWire is a medical device company focused on the design and development of devices for minimally invasive spine surgery. Wyatt Geist is the founder, chairman and CEO of Safewire, and he has developed and patented many devices. Ray Johnson currently serves as CFO of the company. He also serves as president of Cytonics, a developer of diagnostics and treatments for back and joint pain.
4. The company has thus far developed two products — the Y-Wire 2 and the Tiger Needle. The needle is designed to improve the placement of the Y-wire to desired depth within the vertebral body.
5. Several minimally invasive spine surgery systems have entered the market recently, including AccelSPINE's Picasso II system, which received FDA clearance earlier this month. The system is intended to immobilize and stabilize spinal segments as a supplement to fusion during the treatment of acute and chronic instabilities or deformities of the spine.
Also, the spine surgery device market is expected to be worth $14.8 billion by 2017, according to a MarketsandMarkets report. The market was valued at $11.6 billion in 2012 and is expected to grow at a compound annual growth rate of 5.1 percent through 2017.
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