Results from the study were presented by Dr. William Gray of Wynnewood, Penn.’s Lankenau Heart Institute at the Cardiovascular Research Technologies 2018 interventional cardiology conference in Washington D.C., the St. Paul, Minn.-based company said.
“The 18-month Liberty 360° results continue to show that PVI, including the use of orbital atherectomy, can lead to amputation free survival for patients with claudication or critical limb ischemia,” CSI chair, prez & CEO Scott Ward said in a prepared statement.
In the study, researchers explored the use of endovascular device interventions for treating PAD, including those using Cardiovascular Systems orbital atherectomy system.
Data at 18 months indicated a continued 76.9% freedom from major adverse events in Rutherford Classifications 2-3, and 68.2% at Classifications 4-5. At RC 6, major adverse events were also not reportedly driven by major amputation, with a freedom from amputation rate of 81.7%
Quality of life improvements were significantly improved from baseline at 18 months across all arms in the trial, the company said.
In a sub-analysis, Dr. Gray noted that orbital atherectomy treatments had high freedom from major amputations across all Rutherford Classifications, with a 100% rate at RC2-3, 95.3% at RC 4-5 and 91.3% at RC6.
“Liberty 360° represents an unrestricted real-world experience with various endovascular strategies across different RCs, many of whom would never be included in clinical trials, especially, RC6 patients. The results we’ve seen in this novel, all-comers PAD study indicate that endovascular peripheral vascular intervention is a reasonable treatment option for RC2-3, RC4-5 and RC6,” Dr. Gray said in a prepared release.
Earlier this week, Cardiovascular Systems said that the FDA granted 510(k) clearance to the OrbusNeich‘s 1mm Sapphire II Pro coronary balloon, of which Cardiovascular Systems is the exclusie US distributor.