CSI to present CALCIUM 360° Study results at TCT symposium

Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announced today that its CALCIUM 360° Study, the first-of-its kind prospective, randomized feasibility study, demonstrated the safety and effectiveness of plaque modification with the Diamondback 360^® PAD System versus the standard of care treatment (balloon angioplasty) in below-the-knee arteries. This study contributes to a large and growing body of clinical evidence from 1,200 patients in nine clinical trials demonstrating that the Diamondback 360° can predictably treat peripheral arterial disease (PAD) safely and effectively anywhere in the leg. The Diamondback System, developed and manufactured by CSI, is a minimally invasive catheter system that removes hardened plaque to restore blood flow in peripheral arteries.

“Our 360° Clinical Series represents an armada of reproducible evidence giving physicians irrefutable proof of the safety and efficacy of the Diamondback 360° for both above-the-knee and below-the-knee applications. Our commitment to data-driven results will support physicians as they make optimal treatment decisions for their patients with PAD.”

Dr. Nicolas Shammas, Trinity Medical Center, Bettendorf, Iowa, principal investigator of the CALCIUM 360° Study, will present the acute results in a Wednesday, September 22 poster session (No. 411, Hall A) from 1 to 3:30 p.m. at the 22^nd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C., sponsored by the Cardiovascular Research Foundation.

Two additional studies highlighting the acute safety and efficacy advantages of the Diamondback 360° will be presented during the same poster session:

• No. 413: Results of the CONFIRM Registry of 728 Patients to Establish Real-World Application, presented by Dr. Raymond Dattilo, principal investigator, St. Francis Health Center, Topeka, Kansas
• No. 415: Results of the CLEAR 360° Study to Demonstrate Acute Device Safety, presented by Dr. Cezar Staniloae, principal investigator, NYU Medical Center, New York

"Creating a new standard of care for patients with PAD starts with obtaining quality clinical and economic data," said David L. Martin, president and chief executive officer of CSI. "Our 360° Clinical Series represents an armada of reproducible evidence giving physicians irrefutable proof of the safety and efficacy of the Diamondback 360° for both above-the-knee and below-the-knee applications. Our commitment to data-driven results will support physicians as they make optimal treatment decisions for their patients with PAD."

CALCIUM 360° Study Shows Improved Results Over the Current Standard of Care

The CALCIUM 360° Study randomized 50 patients with critical limb ischemia under a common protocol to either orbital treatment with the Diamondback 360° or balloon angioplasty. The primary endpoint of device success of ≤ 30 percent residual stenosis with no dissection Type C-F, as determined by operator visualization angiographically, was met in 92.6 percent of those treated with the Diamondback 360° and 78.8 percent of those treated with balloon angioplasty (p < 0.001). Primary treatment in the orbital arm was followed by low-pressure balloon inflation, while the physician's standard protocol for balloon therapy was used in the alternative arm. Ninety-six percent of the patients had symptoms of critical limb ischemia (Rutherford classes 4-6), and 94 percent had moderately or severely calcified lesions. Six- and 12-month clinical and economic outcomes will be reported as the data becomes available.

"The Diamondback 360° is particularly effective in changing the compliance of calcified lesions prior to low-pressure balloon angioplasty," said Dr. Shammas. "Traditionally, patients with PAD have been treated with high-pressure balloon angioplasty, which is associated with a high rate of dissection and bailout stenting. With the Diamondback 360°, patients with calcified arteries now have an ideal option for restoring flow to heal wounds, save legs and keep patients walking ─ without leaving metal stents in the leg or having to undergo bypass surgery."

CONFIRM DIAMONDBACK Registry Demonstrates Safety, Efficacy Results in Challenging, Real-World Population

The CONFIRM DIAMONDBACK Registry further validates the acute safety and efficacy of the Diamondback 360° System in a real-world setting. This prospective, single-arm study enrolled 728 patients by 84 physicians at 57 centers. All patients considered candidates for treatment with the Diamondback 360° by the physician were enrolled consecutively.

"This registry demonstrates the benefits of changing lesion compliance with the Diamondback 360°, followed by low-pressure adjunctive balloon angioplasty, if desired, in a very large and challenging patient cohort," said Dr. Dattilo. "Data from this study show that the entire leg can quickly, safely and effectively be treated by a multitude of physicians with variable experience and treatment philosophies." CONFIRM results include a low rate of procedural events (0.5 percent perforations, 1.2 percent abrupt closure/no flow and 0.7 percent macro embolization), predictable plaque removal with a final residual stenosis of 10.5 percent, and a low bailout stent rate due to dissection (2.2 percent).

CLEAR 360° Study Provides Additional Safety Data

The potential for hemolysis (a breakdown of red blood cells) as a side effect of orbital atherectomy treatment was evaluated for its clinical significance in the CLEAR 360° Study. Results of 31 patients at four enrolling centers showed that no clinically significant hemolysis was found in any subject.

360° Clinical Series of Studies Under Way

CSI's 360° Clinical Series — including the CONFIRM, CALCIUM 360° and CLEAR 360° Studies — is designed to demonstrate successful acute outcomes, durable long-term results and the economic feasibility of orbital PAD treatment. Other studies under way include the COMPLIANCE 360° Study to evaluate the effectiveness of changing lesion compliance with the Diamondback 360° versus treatment with balloon angioplasty in calcified above-the-knee arteries and the CONFIRM PREDATOR registry to collect information on the newly released Diamondback Predator 360™ PAD System.