LAS VEGAS and MARLBOROUGH, Mass., Oct. 5, 2021 /PRNewswire/ -- Today, Boston
Scientific (NYSE: BSX) announced positive results for the Ranger™
Drug-Coated Balloon (DCB) during a late-breaking clinical trial
presentation at the Vascular InterVentional Advances (VIVA) meeting
in Las Vegas. The data included
two- year results from the RANGER II SFA randomized controlled
trial, confirming the safety and efficacy of the Ranger DCB
compared to standard percutaneous transluminal angioplasty (PTA)
for the treatment of patients with peripheral artery disease (PAD)
in the superficial femoral artery (SFA) and proximal popliteal
artery (PPA).
Following the positive one-year results of RANGER II SFA, which
were published in the Journal of American College of
Cardiology, the new two-year results found that the Ranger DCB
exhibited a significantly higher primary patency rate – a measure
of the target vessel remaining unobstructed at two years – of 84.0%
compared to 71.4% percent in patients treated with standard PTA
(p=0.0129).i Additionally, subgroup analyses found
consistent benefit with greater long-term patency in patients with
more complex lesions treated with the Ranger DCB, exhibiting an
89.1% versus 72.4% primary patency rate in the moderate to severe
calcium subgroup (p=0.0052) and a 76.6% compared to a 58.6% primary
patency rate in patients with chronic total occlusions
(p=0.1038).i
"These two-year data demonstrate a sustained, high rate of
efficacy including in patients with more complex lesion subtypes,
yet another proof point for physicians to consider when determining
the best individualized treatment option for their patients with
PAD," 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.ii
The Ranger DCB, which has a low drug dose density of paclitaxel,
also demonstrated a significant reduction in reinterventions at two
years with a freedom from target lesion revascularization (TLR)
rate of 87.4% versus 79.5% observed with standard PTA
(p=0.0316).i Additionally, there was no significant
difference in all-cause mortality with a 5.7% rate for the patients
treated with Ranger DCB and 3.2% in patients treated with standard
PTA (p=0.4218).
"We're very pleased to see that the Ranger DCB exhibited
excellent, sustained results at two years and it is particularly
gratifying that the RANGER II SFA subgroup analyses found no
reintervention disadvantage for women, who have historically
experienced greater patency challenges following endovascular
intervention for PAD," said Michael R.
Jaff, D.O., chief medical officer and vice president
clinical affairs, technology and innovation, Peripheral
Interventions, Boston Scientific.
Late-breaking results from the EMINENT trial, which evaluated
the Eluvia™ Drug-Eluting Stent vs. bare-metal stents, will be
presented tomorrow, October 6, at the
VIVA21 conference.
For more information on the Ranger DCB, visit
https://www.bostonscientific.com/rangerclinicaltrials.
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 more than 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 and connect on Twitter and Facebook.
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914
Karin.Dalsin@bsci.com
Lauren Tengler
Investor Relations
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BSXInvestorRelations@bsci.com
i Kaplan Meier Estimate
ii Dr. Ravish Sachar is a paid consultant for Boston
Scientific Corporation. He has not been compensated for his quote
within this press release.
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SOURCE Boston Scientific Corporation