C.R. Bard (NYSE:BCR) subsidiary Bard Peripheral Vascular touted results showing no significant difference in a study pitting its Lutonix DCB against Medtronic‘s (NYSE:MDT) In.Pact DCB in treating patients with complex femoropopliteal lesions.
Clinical data from the investigator-sponsored retrospective, single-center study was presented during the Leibzig International Course in Leipzig, Germany last month.
The study reported no statistically significant difference between Lutonix and In.Pact patients at 18 months in rates of target lesion revascularization and sustained clinical improvement. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to the DCB treatment, the company said.
“These single-center results, like others before, show that real-world patients are benefiting from drug-coated balloon technology; and furthermore, the study indicates that there is no significant difference in the need for revascularization following treatment with either of these two DCBs,” Dr. Dierk Scheinert of Germany’s University of Leipzig said in a press release.
In total, data from the treatment of 575 limbs were included in the study, with 398 treated with Medtronic’s In.Pact and 177 treated with the Lutonix. Lutonix patients demonstrated a 73.1% freedom from TLR rate at 18 months, compared with a 74.8% rate for those treated with the In.Pact.
Lutonix patients reported a 66.4% rate of Rutherford class improvements at 18 months, while those treated with the In.Pact reported a 59.5% rate of improvement.
Last October, Bard released 2-year results from a small group of patients in a real-world registry study of its Lutonix drug-eluting balloon at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco.
Bard said the Lutonix 035 device showed a 94.3% rate of freedom from target lesion revascularization in 631 patients at 12 months. A smaller group of 170 patients who were early enrollees in the study showed a 93.0% rate of TLR freedom at 24 months, Murray Hill, N.J.-based Bard said. Last June, 2-year data from Bard’s Levant 2 trial showed an 82% TLR freedom rate.
