Boston Scientific Receives FDA Approval for the Ranger? Drug-Coated Balloon
MARLBOROUGH, Mass.,?Nov. 2, 2020?/PRNewswire/ -- Boston Scientific (NYSE:?BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the Ranger? Drug-Coated Balloon, developed for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
Approximately 200 million people around the world are affected by PAD1, a common circulatory problem in which plaque builds up and narrows arteries, consequently reducing blood flow to limbs. The Ranger DCB was designed with a low therapeutic drug dose and proprietary coating which efficiently transfers the drug into the tissue, resulting in high primary patency rates and low systemic drug exposure for patients. The low-profile platform of the balloon also assists clinicians in performing streamlined procedures and navigating through challenging anatomy in order to deliver consistent therapy.
"This approval allows us to bring more treatment options with exceptional outcomes and proven safety to U.S. physicians and their patients who are facing this challenging disease," said?Jeff Mirviss, president, Peripheral Interventions, Boston Scientific. "Adding the Ranger DCB to our drug-eluting portfolio, which also includes our Eluvia? Drug-Eluting Vascular Stent System, reinforces our commitment to providing differentiated technology with strong clinical evidence that supports data-driven treatment decisions for millions of patients suffering from PAD worldwide."
The FDA approval is based on results from the RANGER II SFA pivotal trial, which evaluated the safety and effectiveness of the Ranger DCB versus standard percutaneous transluminal angioplasty (PTA) for the treatment of patients with PAD in the SFA and PPA. In the randomized controlled trial, both primary endpoints were met:
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(763) 494-1914 (office)
Karin.Dalsin@bsci.com Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com [1] Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018;275:379-381.
2?RANGER II SFA Pivotal Trial 12-Month Results presented by?Marianne Brodmann, M.D. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 82.9% for Ranger DCB and 66.3% for PTA (p= <0.0017). Freedom from Major Adverse Events = 94.1% for Ranger DCB and 83.5% for PTA (p?<0.0001)
3?COMPARE Clinical Trial 12-Month Results presented by?Sabine Steiner, M.D. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 83.0% for Ranger DCB and 81.5% for IN.PACT DCB (p <0.01). Freedom from Major Adverse Events = 91.0% for Ranger DCB and 92.6% for IN.PACT DCB (p<0.01).
4?Based on total drug dose for 4mmx60mm or averages for full size matrix per the IN.PACT? Admiral? Drug-Coated Balloon Instructions for Use,?www.medtronic.com?and the Ranger? Drug-Coated Balloon Instructions for Use. SOURCE Boston Scientific Corporation
- The primary safety endpoint of 12-month freedom from major adverse events (MAE) was 94.1% for those treated with the Ranger DCB versus 83.5% for standard PTA (Pnon-inferiority <0.0001).2
- Additionally, patients who received therapy with the Ranger DCB had a significantly lower target lesion revascularization rate ? a component of MAE ? of 5.5% in contrast to 16.5% observed with standard PTA (p=0.0011), substantially reducing a patient's need for repeat procedures.2
- The primary efficacy endpoint of 12-month binary primary patency ? a measure of the target vessel remaining unobstructed ? was 82.9% for the Ranger DCB and 66.3% for standard PTA (p=0.0017). Primary patency by Kaplan-Meier estimate was 89.8% for the Ranger DCB and 74.0% for PTA at 12 months (p=0.0005).2
Media Relations
(763) 494-1914 (office)
Karin.Dalsin@bsci.com Susie Lisa, CFA
Investor Relations
(508) 683-5565 (office)
BSXInvestorRelations@bsci.com [1] Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018;275:379-381.
2?RANGER II SFA Pivotal Trial 12-Month Results presented by?Marianne Brodmann, M.D. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 82.9% for Ranger DCB and 66.3% for PTA (p= <0.0017). Freedom from Major Adverse Events = 94.1% for Ranger DCB and 83.5% for PTA (p?<0.0001)
3?COMPARE Clinical Trial 12-Month Results presented by?Sabine Steiner, M.D. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 83.0% for Ranger DCB and 81.5% for IN.PACT DCB (p <0.01). Freedom from Major Adverse Events = 91.0% for Ranger DCB and 92.6% for IN.PACT DCB (p<0.01).
4?Based on total drug dose for 4mmx60mm or averages for full size matrix per the IN.PACT? Admiral? Drug-Coated Balloon Instructions for Use,?www.medtronic.com?and the Ranger? Drug-Coated Balloon Instructions for Use. SOURCE Boston Scientific Corporation