Avinger today released data from the pivotal vision study of its Pantheris system, touting high survivability and freedom from target lesion revascularization in patients treated with the system.
The 89-patient Vision study aimed to evaluate the safety and effectiveness of its Pantheris directional atherectomy system which uses real-time intravascular imaging to remove plaque from diseased lower extremity arteries.
The Redwood City, Calif.-based company said that all primary and secondary endpoints of the trial were achieved.
Results from the trial were presented at the New Cardiovascular Horizons meeting in New Orleans by Dr. Patrick Muck of Cincinnati’s Good Samaritan Hospital.
“The complete Vision 24-month data demonstrates positive longer-term sustained results for patients treated with Pantheris, and importantly, these patients have largely avoided the need for a repeat procedure in a two-year timeframe. Considering that the outcomes were generated at the hands of brand new users with a first-generation clinical trial device, such positive results represent an important step forward for Pantheris in the clinical setting,” Dr. Muck said in a prepared statement.
Data indicated an 82% freedom from TLR at 12 months and 74% freedom from TLR at 24 months, with Kaplan Meier freedom from TLR at 24 months remaining stable between 18 and 24 months, the company said. Results also indicated statistically significant improvements in ankle brachial index and Rutherford classification at 30 days, which were maintained through 2 years.
Avinger said that a majority of lesions treated in the study were treated using standalone optical coherence tomography guided atherectomy with the Pantheris catheter. Only 9.6% of patients received adjunctive drug coated balloon therapy, and only 5% received adjunctive stent therapy.
“These excellent results continue to reinforce our enthusiasm for the Pantheris System. We are gratified that Lumivascular technology is improving the lives of patients with PAD, including many facing amputation. In the meantime we continue to refine the system, with Pantheris 3.0, our next-generation atherectomy catheter, and a lower-profile Pantheris device currently in development,” founder & exec chair Dr. John Simpson said in a press release.