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:
- 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
"The Ranger DCB eases deliverability for a wide range of lesion
complexities via a low profile platform that is compatible with
smaller diameter guidewires and has shown consistent results in
multiple randomized controlled trials," said Ravish Sachar, M.D.,
UNC Rex Hospital Physician-in-Chief for Heart and Vascular services
and principal investigator of the RANGER II SFA trial. "For
physicians seeking to limit systemic drug loss without compromising
outcomes, data demonstrate the Ranger DCB is a safe and effective
treatment option."
The Ranger DCB also demonstrated nearly 90% primary patency in
the investigator-sponsored COMPARE trial3 – the first
head-to-head prospective, randomized controlled trial to compare
two different DCBs. In the trial, the Ranger DCB demonstrated a
similar primary patency rate of 88.4% to that of the 89.4% observed
with IN.PACT™ Admiral™ Drug-Coated Balloon (Medtronic) by
Kaplan-Meier estimate (p=0.81), with a significantly lower drug
dose density (2 µg/mm2 paclitaxel versus 3.5 µg/mm2 paclitaxel,
respectively).3,4
Boston Scientific expects to initiate a registry of the Ranger
DCB and the Eluvia stent in the coming months to gather additional
real-world evidence, which will add to the breadth of clinical data
collected on these devices to date. The registry is expected to
include five years of patient follow-up with an emphasis on
enrolling patient populations who have been historically
underrepresented in clinical trials studying treatments for
PAD.
The company announced CE Mark for the Ranger DCB in 2014 and
plans to immediately launch the device in the U.S.
For more information on the Ranger DCB, visit
http://www.bostonscientific.com/ranger.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for 40 years, we advance science
for life by providing a broad range of high performance solutions
that address unmet patient needs and reduce the cost of healthcare.
For more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
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This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
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"anticipate," "expect," "project," "believe," "plan," "estimate,"
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regarding our business plans, product launches and product
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have affected and in the future (together with other factors) could
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CONTACTS:
Karin Dalsin
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.
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SOURCE Boston Scientific Corporation