C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease. Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the […]
C.R. Bard
Bard touts data from Lutonix head-to-head study against MDT's In.Pact
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 […]
Bard, Medtronic win Medicare reimbursement add-on for DCBs
Medtronic (NYSE:MDT) and C.R. Bard (NYSE:BCR) said today that angioplasty treatments with drug-coated balloons will now be eligible for new technology add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems. The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients for peripheral artery disease with […]
