A build-up of the fatty substance known as plaque can narrow the arteries causing peripheral arterial disease (PAD). Angioplasty typically flattens the blockage to the artery walls. But if it's a chronic total occlusion (CTO) – a complete blockage – a catheter is often used to jam through, or to go around with a risk of piercing the vessel wall. FlowCardia's (Sunnyvale, California) Crosser Catheter works like a mini jackhammer, using vibrational energy – at a rate of 20,000 cycles per second – to deftly create a path through.
Although the Crosser was FDA approved for marketing in 2007 (Medical Device Daily, Dec. 12, 2007), a new study has just been launched to prove that this catheter can help interventional cardiologists to stay within the central lumen of an artery better than any other catheter.
"It's not a brand new indication; we're just demonstrating the concept," a company spokesman told Medical Device Daily.
This week, FlowCardia reported that the first patient has been successfully enrolled into the Crosser ENters The Right Arterial Lumen (CENTRAL) study. Principal investigator John Paul Runyon, MD, from The Christ Hospital (Cincinnati) successfully enrolled the first patient into the study.
"The acute benefits of staying within the central lumen and not causing trauma to the artery wall are well documented and we are excited to be involved in this study," said Runyon, an interventional cardiologist at The Christ Hospital. "Most treatment options for PAD require staying in the central lumen to be most effective. Using the Crosser Catheter as a front line therapy allows us to use further treatment options resulting in increased long term benefits to the patient."
The eight-hospital, 100-patient CENTRAL study is designed as a single arm registry that involves recanalizing the occlusion and demonstrating successful navigation of the Crosser Catheter in the central lumen of the artery as confirmed by intravascular ultrasound. Also noted in the study, will be the re-entry ratio or utilization rate of lumen re-entry devices during CTO recanalization procedures. When CTOs are crossed within the central lumen of the artery, the need for these re-entry devices is dramatically reduced.
"This unique study will validate the Crosser Catheter's ability to provide treatment while staying within the central lumen of the artery to a greater degree than the currently available recanalization devices and techniques," said national principal investigator of the CENTRAL study, Tom Davis, MD, of St. John Hospital and Medical Center (Detroit).
The Crosser CTO Recanalization Catheter is a minimally-invasive endovascular device that is delivered to the blockage within the artery using standard guidewire techniques. The cardiologist then activates the Crosser Catheter which uses high-frequency, mechanical vibration to pass through the blockage in the central lumen of the artery. Once the Crosser Catheter passes through the occlusion, physicians can then perform standard procedures to optimize the longer term outcomes.
Lynn Yoffee, 770-361-4789;