The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won CE Mark approval in the European Union.
“The expansion of In.Pact Admiral DCB to 150mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment,” peripheral unit general manager Mark Pacyna said in prepared remarks. “The In.Pact Admiral platform continues to show durable, consistent, and safe outcomes.”
“The long lesion (10cm to 18cm) sub-group outcomes from the In.Pact SFA trial at 1 year demonstrated superiority over balloon angioplasty,” added co-principal investigator Dr. John Laird, of California’s U.C. Davis Medical Center. “The availability of the 150mm length sizes will expand proven treatment options to more patients.”
Medtronic said the trial showed that the target lesion revascularization for the longer lesions was 5.3%, compared with 32.4% for patients treated with percutaneous transluminal angioplasty, with no device- or procedure-related deaths, no amputations and a 3.9% blood clot rate at 12 months (compared with 5.9% for the PTA cohort).
In April, Medtronic released a bevy of data from 3 different studies of the device at the 2016 Charing Cross Symposium in London, including 1-year results from a chronic total occlusion imaging cohort and 2-year gender and diabetic subgroup analysis.
Data from a chronic total occlusion imaging cohort of 126 patients with average lesion lengths of 22.9cm indicated an 84.4% primary patency rate and 12.2% TLR rate. Additional data indicated a 4.3% rate of all-cause mortality, a 4.3% rate of thrombosis and no amputations.
A separate presentation presented data from a gender and diabetes analysis cohort from the In.Pact SFA trial, which examined females and patients with diabetes. Data from a cohort of 113 female patients, from a total of 331 patients enrolled in the trial, returned a 76.7% patency rate at 2 years, compared to 42.3% in PTA-treated patients. Data from the female cohort indicated a 13.2% TLR rate, compared to 38.2% in the balloon angioplasty arm.
And a separate evaluation of patients with diabetes indicated similar results between those without diabetes, with patency rates of 73.3% in patients with diabetes and 82.5% in patients without. In the balloon angioplasty arm, data from patients with diabetes indicated a 45.8% patency rate and 54.5% for the non-diabetic arm. Diabetes patients reported a 10.7% TLR rate versus 8.1% rate in non-diabetics.