Cardiovascular Systems has announced that two patients at two different hospitals were treated with its new, 6 French guide catheter-compatible, electric orbital atherectomy system. The treatments are part of the company’s ORBIT II trial, which is now over 70% enrolled. ORBIT II is evaluating the safety and effectiveness of the company’s orbital technology in treating calcified coronary arteries.
Rohit Bhatheja, an interventional cardiologist at Florida Hospital Orlando in Orlando, USA and Rakesh Shah, an interventional cardiologist at St Mary Medical Center in Langhorne, USA, enrolled the first patients with the new electric coronary system. Bhatheja said, “This new electric system is very easy to use, and the setup time only takes a few seconds.” Rakesh added, “The new lower profile system allows me more access site options, so I can treat a broader patient population.”
“Treating patients with our most advanced coronary system in the ORBIT II trial is a key accomplishment, as we work to secure a coronary indication in the United States. Using orbital technology in calcified coronary arteries may lead to a new treatment paradigm for more effective stent placement, avoiding the trauma and cost of retreatment or heart bypass surgery. Our technology showed excellent results in the ORBIT I feasibility trial, and we anticipate similar results in ORBIT II,” said David L Martin, president and CEO, Cardiovascular Systems.
The atherectomy system uses the company’s orbital mechanism of action that protects healthy tissue while removing even the most difficult to treat plaque. The advanced, electric-powered handle features a power on/off button and speed selection controls conveniently positioned for ease of use and greater physician control. By eliminating the compressed air tank and separate speed controller of the previous coronary systems, this new system significantly reduces device set-up and lab-staff time.
Cardiovascular Systems received unconditional FDA IDE approval for the ORBIT II study in April 2010, and more than 45 US medical centres are enrolling patients. The company expects to complete patient enrolment early autumn of 2012. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, USA, is the principal investigator for the ORBIT II study. The primary endpoints of ORBIT II are based on a 30-day patient follow-up post procedure. The company expects to submit a premarket approval application to the FDA soon after enrolment completion.