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 22nd 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."
Source : Cardiovascular Systems, Inc.