TRUTH Shows Efficacy of CSI's Peripheral Orbital Atherectomy Systems

September 15, 2014—Cardiovascular Systems, Inc. (CSI) announced that data from the company’s TRUTH (Tissue Removal Assessment With Ultrasound of the Superficial Femoral Artery [SFA] and Popliteal) study were reported at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.

TRUTH evaluated the removal of plaque with CSI’s peripheral orbital atherectomy system (OAS) by analyzing changes in plaque volume and composition via an independent virtual histology intravascular ultrasound core laboratory. TRUTH is a prospective, single-arm, nonrandomized feasibility study of 25 patients.

“TRUTH demonstrates that by using CSI’s peripheral atherectomy systems, physicians can improve procedural success in calcified lesions. The study also highlights the unique capabilities of our orbital technology and CSI’s commitment to providing physicians new options for treating the most difficult patients,” commented David L. Martin, CSI’s President and Chief Executive Officer, in the company’s press release.

The poster presentation by Anvar Babaev, MD, et al highlighted TRUTH study results demonstrating that OAS treatment is effective at reducing and modifying calcium from lesions, resulting in low acute complications and improved Rutherford classification (RC).

Key TRUTH results included: all patients were asymptomatic 2 weeks after OAS treatment (RC of 0 [100% asymptomatic] compared to a baseline RC of 3 (96%); 100% freedom from recoil, slow flow/no reflow, flow-limiting dissections, or perforations after OAS treatment; at the treated lesion site, the minimum lumen area increased significantly from 4 mm² to 9.1 mm² after treatment (P < .0001), accompanied by a decrease in area stenosis; at the site of maximum calcium removal, calcium reduction was responsible for 86% of the lumen area increase; and calcium modification was directly related to OAS usage.

The company advised that the CSI Stealth 360º and Diamondback 360º peripheral OASs use a diamond-coated crown, attached to an orbiting shaft, which sands away plaque while preserving healthy vessel tissue. The company’s OASs treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time and address many of the limitations associated with existing surgical, catheter, and pharmacological treatment alternatives.

The US Food and Drug Administration (FDA) granted 510(k) clearance for the use of the Diamondback OAS for the treatment of PAD in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback OAS in coronary arteries.