Orbit Artherectomy System (Cardiovascular Systems) filed at FDA to treat Calcified Arteries

Cardiovascular Systems (CSI) has announced it has submitted its Premarket Approval (PMA) application to the FDA for its Orbital Atherectomy System, used to treat calcified coronary arteries.

The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI's technology produced clinical outcomes that exceeded the trial's two primary safety and efficacy endpoints by a significant margin�within one of the most challenging patient populations.Data that showed a 30-day freedom from MACE (major adverse cardiac events) rate of 89.8 percent and procedural success of 89.1 percent (including in-hospital MACE).

The FDA agreed to a modular PMA process that allowed CSI to submit the first two modules covering preclinical data and manufacturing/quality systems, while still collecting, compiling and analyzing the clinical data. CSI has now submitted the third and final PMA application module, as well as responses to FDA comments on the first two modules, which were submitted in late 2012.

The Orbital Atherectomy System treats calcified and fibrotic plaque in arterial vessels throughout the leg in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.