Cierra, Inc. Receives Frost & Sullivan Interventional Cardiology Excellence in Research of the Year
Mar 16, 2006 - Frost & Sullivan's 2006 Excellence in Research of the Year Award in the field of interventional cardiology goes to Cierra, Inc. for its outstanding research and development efforts that lead to the introduction of the PFX™ Closure System, a novel approach to the treatment of Patent Foramen Ovale (PFO). This catheter-based system has for the first time achieved clinical PFO closure without leaving behind an implant.
A PFO results from the incomplete closure of the wall between the left and right atria (upper chambers) of the heart. The opening exists before birth to allow oxygenated blood to circulate throughout the fetus without having to pass through its lungs. The foramen ovale usually closes after birth in 75% of adults however, for one in four adults, the PFO does not seal completely and blood can move directly, under certain conditions, from the right atrium to the left atrium, bypassing filtration by the lungs. In these cases blood clots and/or other agents present in the blood can bypass the lungs and pass directly into the arterial system, potentially causing a stroke. The presence of PFO has also been associated with migraine headache.
Existing PFO closure methods using implantable devices have offered patients a significant improvement over open-heart surgery, and tens of thousands of PFOs have been closed with implants in the past half-decade. But despite the benefits of implants, they have been associated with permanent residual shunts, and with safety issues such as tissue erosion, thrombus formation and embolization, and other problems.
Safety is paramount for the otherwise healthy, young migraineur who faces the likelihood of a long healthy life ahead. Cierra's novel system closes PFO using "tissue welding" without utilizing an implant. This is done percutaneously using radio frequency (RF) energy that is delivered through Cierra's proprietary system. The delivery catheter remains entirely within the right atrium, minimizing risks associated with devices in the left atrium. Vacuum is applied through the catheter to hold the tissues of the PFO together during RF energy application, and the complete clinical procedure takes less than a half-hour to perform. Thirty-seven patients have been treated to date with very good results.
The company anticipates the receipt of a CE mark and commercialization of the system in Europe in 2006 with US approval coming later this decade. Prior to receiving FDA approval in the US, Cierra will complete a pivotal clinical trial in migraine patients.
To protect its intellectual property, the company has filed a portfolio of patents, and plans to continue to add to its intellectual property position. The first issued patent covers the company's current method of treating PFO.
Cierra is the seventh portfolio company from the medical device incubator, The Foundry, and is privately held. Its venture investors are Split Rock Partners, Morgenthaler Ventures, Frazier Healthcare Ventures and Delphi Ventures.
In conclusion, Frost & Sullivan's Award for Excellence in Research of the Year recognizes Cierra, Inc.'s significant R&D efforts towards the development of its groundbreaking PFX Closure technology, a catheter system for non-implant-based PFO closure.