Kentucky's Therix Medical last week announced the launch of spinoff Bluegrass Vascular Technologies, which is focusing on developing products to improve patient outcomes in vascular access procedures.
Bluegrass' flagship product is the Surfacer inside-out access catheter system, which was developed to provide a new option for upper extremity venous occlusion that makes the vein impenetrable by a guide wire or standard access techniques. Using the system, physicians insert a guide wire through the femoral vein in the groin area and navigate up through the torso with an exit point in either the jugular or subclavian vein using fluoroscopy.
"The idea for the Surfacer was born from seeing many patients with obstructed central venous systems who needed life-saving vascular access therapies, whether that be pacemakers or defibrillators or dialysis access," said Bluegrass CMO Dr. John Gurley, who invented the Surfacer. "Our unique system offers physicians an innovative yet simple solution. If the veins are obstructed and you can't put a needle in from the outside, you can now go inside the body and direct the needle out."
Bluegrass anticipates completion of a first-in-man study using the Surfacer by the end of the year. In addition, the company will seek CE Mark approval for Surfacer first, then come back to the FDA for clearance in the U.S., Therix CEO Jim Clifton, who is also Bluegrass' president, told FierceMedicalDevices. And while Bluegrass is focused "like a laser beam" on Surfacer, a possible family of technologies isn't out of the question, Clifton told FMD.
Therix was founded in late 2007 to capitalize on the opportunity to commercialize product concepts from clinicians at the University of Kentucky and other regional medical centers. Clifton told FMD that his company has heard about an array of technologies from U.K. clinicians; however, they don't always have the capability to get their ideas to market. Therix is working with clinicians to get these promising Class I and II medical devices and diagnostics to market.
- see the Therix release