Cardiovascular Systems has completed enrolling 443 patients in the ORBIT II trial of its electric orbital atherectomy system (OAS), designed to treat severe calcified coronary arteries.
The first premarket approval (PMA) trial, which is designed to assess the safety and effectiveness of the device, has randomized patients in which 343 were treated with the company’s original pneumatic OAS and 100 with the new electric OAS.
The primary endpoints for the FDA investigational device exemption approved trail will be based on a 30-day patient follow-up post procedure.
Metropolitan Cardiovascular Consultants interventional cardiologist and study principal investigator Dr Jeffrey Chambers said based on promising results in treating severely calcified coronary arteries in the ORBIT I study, Cardiovascular Systems’ orbital technology will be well suited for removing calcified plaque in coronary lesions.
"I look forward to seeing the results from ORBIT II and I’m hopeful that we will have a new therapy in the near future for these difficult-to-treat patients."
The company anticipates that the PMA will be final on submission of module 3 which includes ORBIT II clinical data and proposed labeling.
The PMA filing, which included modules 1 (preclinical) and 2 (manufacturing/system quality), will occur in early 2013, according to the company.