Cardiovascular Systems (NSDQ:CSII) today released both 1-year and a sub-analysis results from the Liberty 360 clinical trial of peripheral interventions, including those using its DiamondBack 360 coronary orbital atherectomy system.
The 1,200 patient study aimed to evaluate acute and long-term clinical outcomes of peripheral interventions for patients with peripheral artery disease, with the most common device used being the company’s Diamondback 360, the St. Paul, Minn.-based company said.
1-year outcomes were presented at the 2017 Amputation Prevention Symposium in Chicago by Dr. Jihad Mustapha of Michigan’s Metro Health Hospital.
“Our commitment to clinical rigor is key to our success and growth plans. The Liberty 360 study continues to reinforce the importance of endovascular intervention for this difficult-to-treat patient population, with a particular focus on amputation prevention for patients with PAD, and specifically critical limb ischemia,” prez & CEO Scott Ward said in a press release.
Results from the trial indicated that at 12 months, individuals with critical limb ischemia spanning Rutherford Classifications between 4 and 5 had a 96% freedom from amputation, while those with an RC6 rating had an 81.7% freedom from amputation. Data also indicated that CLI patients had improvements in RC, wound healing and quality of life.
“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 one year, as well as high freedom from major adverse events. In particular, Liberty 360 provides new, compelling evidence that PVI can lead to amputation free survival in CLI patients and serves as a patient-centric alternative to primary amputation,” Dr. Mustapha said in a prepared release.
In its sub-analysis, Cardiovascular Solutions examined freedom from major adverse events and major amputation for patients treated with its Diamondback 360 device.
Results from the sub-analysis indicated that patients treated with the Diamondback reported statistically similar major adverse event outcomes at 12 months for patients with RC 4-6 patients, and high freedom from major amputations across all Rutherford classes.
Cardiovascular Systems said that patients receiving vessel preparation with the Diamondback prior to drug-coated balloon therapy reported a 95.2% rate of freedom from major adverse events at 12 months with no major amputations.
“These findings show that patients treated with our innovative orbital atherectomy device experienced positive clinical outcomes such as high freedom from major adverse events and freedom from major amputation. It further validates OAS as an effective treatment option for patients suffering from severe forms of PAD,” CEO Scott Ward said in a prepared statement.
The post Cardiovascular Systems touts 1-year, sub-analysis data from Liberty PVI study appeared first on MassDevice.