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Results From Cardiovascular Study Published

Fri, 08/31/2012 - 4:43am

(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today announced publication of 12-month results from its CALCIUM 360° study in the Journal of Endovascular Therapy.

CALCIUM 360° is a prospective, randomized, multi-center study of 50 patients (64 lesions), comparing one-year safety and efficacy of CSI’s Diamondback 360° atherectomy device followed by percutaneous transluminal angioplasty (PTA), versus PTA alone, to treat calcified infrapopliteal lesions in patients with critical limb ischemia.

Based on the study results, the Diamondback 360° system provides significantly lower major serious adverse events (major amputation, all-cause mortality, and TLR/TVR) than PTA alone. The Diamondback arm demonstrated that lower balloon pressure is needed to achieve optimal dilatation (p <0.001), resulting in fewer procedural events for peripheral arterial disease (PAD) patients. At 12 months, the Diamondback 360° group was 93.3 percent free of major adverse events (major amputation, all-cause mortality and TLR/TVR) versus just 57.9 percent of the balloon angioplasty alone (p = 0.006) group.

 

 

 

Diamondback 360°

 

 

Balloon Angioplasty

Average maximum balloon pressures*

 

 

5.9 atms (p<0.001)

 

 

9.4 atms

Procedural success (≤30% residual stenosis)*

 

 

93.1%

 

 

82.4%

Dissections*

 

 

3.3%

 

 

11.4%

Bail-out stenting*

 

 

2 (6.9%)

 

 

5 (14.3%)

Freedom from revascularization**

 

 

93.3%

 

 

80.0%

Free of major adverse events**

 

 

93.3% (p=0.006)

 

 

57.9%

(*Per lesion ** Per patient)

According to David L. Martin, CSI president and CEO, “The CALCIUM 360° study demonstrates that our technology provides patients and physicians with a better therapy. It provides optimal balloon dilatation and significantly lowers complications. Our expanding clinical data set continues to demonstrate that the Diamondback 360° system is setting a new standard for treating calcified lesions.”

The CALCIUM 360° study builds on CSI’s history of clinical evidence and positive outcomes already seen in CSI’s OASIS and COMPLIANCE 360° trials. Studies demonstrate sustained durability and low revascularization rates for CSI’s orbital atherectomy systems with low-pressure PTA.

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