Cardiovascular Systems (NSDQ:CSII) yesterday released two-year results from the Liberty 360 study examining long-term clinical and economic outcomes for peripheral vascular interventions in treating patients with peripheral artery disease.
Results from the trial were presented by Dr. Jihad Mustapha of Grand Rapids, Mich.’s Advanced Cardiac & Vascular Amputation Prevention Centers in a late-breaking presentation at the 2018 Amputation Prevention Symposium in Chicago.
In the 1,204-patient “all comers” study, investigators examined effects of treatment with a number of different FDA-cleared devices for treating PAD, including the St. Paul, Minn.-based company’s orbital atherectomy system.
Results from the study indicated high rates of freedom from major amputation across all Rutherford Classifications at two years, with class 2-3 patients experiencing a 99.1% rate, class 4-5 patients experiencing a 94.5% rate and class 6 patients experiencing a 79.8% rate of freedom from major amputation.
A sub-analysis of orbital atherectomy showed an even higher rate of freedom from major amputation across RC classes, with RC2-3 experiencing a 100% rate, RC4-5 experiencing a 95.3% rate and RC6 experiencing an 88.5% rate.
“Liberty 360° represents as close to a real-world experience as possible with various endovascular strategies across Rutherford Classes. Following endovascular intervention, we saw a marked improvement across all Rutherford Classes at two years, as well as high freedom from major amputation. In particular, Liberty 360° provides compelling evidence that PVI can lead to amputation free survival even in RC6 patients, which showed a 79.8% freedom from major amputation following PVI,” Dr. Mustapha said in a press release.
“The two-year Liberty 360° results continue to show that PVI, including the use of orbital atherectomy, can lead to amputation free survival for patients with mild to severe PAD, even critical limb ischemia,” prez & CEO Scott Ward said in a press release.
Late last month, Cardiovascular Systems said that it inked a development agreement with Aerolase for a laser atherectomy system designed for treating multiple arterial diseases.
