Radius Medical, LLC. today announced the FDA clearance and product launch of its new PRODIGY™ Support Catheter. Engineered to provide back up support to the guidewire when encountering difficult to cross lesions, the PRODIGY Support catheter will be a critical component in the revolutionary techniques now being developed in treating chronic total occlusions.
The Prodigy Support catheter is uniquely designed to deliver exceptional support in even the most challenging cases. It provides an easy, safe solution to stabilize the catheter within the vessel for enhanced guidewire pushability. The device includes a novel elastomeric balloon that allows for anchoring of the catheter within the vessel. The balloon material allows for a single balloon to cover a full range of vessel diameters, from 2-6mm.
"The beauty of this 5 French catheter system is that it's compatible with all conventional guiding catheters and its enhanced trackability through tortuous coronary anatomies, said Dr. Richard Heuser, Chief of Cardiology, St. Luke's Medical Center. "What is so remarkable about this device is its soft, atraumatic balloon that provides protection against damage to the vessel wall, especially in critical cases." "I think they've really done their homework here. I've worked with Radius for several years, and Radius has always been in the forefront in meeting clinical needs of physicians, not only interventional cardiologists, but also vascular surgeons, vascular radiologists, and neuroradiologists. This innovative new design is another example of their continued approach to solving unmet clinical needs for physicians and their patients."
Maureen Finlayson, President and CEO of Radius Medical commented, "We are very excited about this new product launch in the U.S. market, and look forward to our launch outside the U.S. into global markets, scheduled for September 2014. We will be featuring this new technological advancement in our sales booth at the upcoming CTO/LM Summit and CRT Meetings in February, as well as the Euro CTO Club meeting in September."