Zacks_Analysts' Blog : CSII Completes Enrollment - Analyst Blog

Cardiovascular Systems, Inc. (CSII) has recently completed patient enrollment in its COMPLIANCE 360 degree clinical trial. COMPLIANCE 360 degree is a prospective, randomized feasibility study that uses CSII’s Diamondback 360 degree System to evaluate the treatment of peripheral arterial disease (PAD) above the knee. CSII’s Diamondback 360 degree System is a minimally invasive catheter used for treating PAD anywhere in the leg.

 

The COMPLIANCE 360 degree clinical trial will evaluate the benefits of removing plaque and improving vessel compliance with the Diamondback 360 degree along with low-pressure balloon therapy, compared to treatment with high-pressure balloon inflation alone. The trial has enrolled 50 patients at nine investigational sites who will be followed for twelve months. The primary endpoint is six-month restenosis or TLR.

 

CSII’s Diamondback 360 degree System has already been tested to be more effective than stents in the treatment of PAD above the knee. The System can remove hard, calcified plaque and achieves more uniform, circumferential lesion compliance for patients. 

The COMPLIANCE 360 degree is part of CSII’s 360 degree clinical studies. Earlier, the company completed enrollment in its CALCIUM 360 degree clinical trials. Both these studies are built upon the already completed OASIS and OASIS long term studies. All these studies are designed to study the safety, effectiveness and durability of the Diamondback 360 degree device in treating peripheral vascular diseases.

CSII develops interventional systems for treating vascular diseases. The company became a public company through the merger with Replidyne, Inc. in early 2009. CSII’s main competitors include Boston Scientific Corporation (BSX) and ev3, Inc. (EVVV).