Minnesota’s Cardiovascular Systems gets FDA approval for Phase 2 coronary trial

Cardiovascular Systems' Diamondback 360 device

St. Paul, Minnesota — Vascular device maker Cardiovascular Systems Inc. has received FDA approval to begin a Phase 2 trial of its Diamond 360 catheter system for patients with heart lesions.

The company says it’s authorized to begin the trial, which it calls Orbit II, sometime early this year and will enroll as many as 100 patients in up to 50 states, according to a statement. The trial is intended to evaluate the system’s safety and effectiveness for the treatment of calcified coronary lesions — formations of plaque that reduce blood flow in coronary arteries.

Assuming the Phase 2 trial is successful, the company projects the device to be on the market for coronary treatment sometime in 2012, a spokeswoman said.

The Diamondback 360 is a minimally invasive catheter, which received FDA marketing clearance in 2007 for the treatment of peripheral arterial disease, a condition in which plaque builds up in veins that carry blood from the heart to the arms and legs.

If the Diamondback receives clearance for treating heart conditions, it could be a big step for Cardiovascular Systems. The company estimates the coronary intervention market at more than $4 billion annually, with 1.3 million procedures a year, according to the statement.

In the Diamondback’s first coronary trial in 2008, the device showed a 98 percent success rate in 50 patients in India.

“A complementary tool to stents and angioplasty, we expect our Diamondback 360 to play a significant role in this market by removing the calcified or fibrocalcific disease to increase the effectiveness of the other therapies,” said David Martin, the company’s chief executive.

For its fiscal year ended June 30, 2009, Cardiovascular Systems reported a net loss of $32 million, an improvement from a loss of $39 million the prior year. The company’s 2009 revenue more than doubled to $56 million. In November, the company announced a recall of its ViperSheath, a catheter sheath that is used for through-the-skin entry of intravascular devices. The sheath was fracturing and stretching during use, the company said at the time.