LAS VEGAS and MARLBOROUGH, Mass., Nov. 5, 2019 /PRNewswire/ -- Today, Boston
Scientific (NYSE: BSX) announced positive data for two devices
within the peripheral drug-eluting product portfolio during
separate late-breaking clinical trial presentations at Vascular
InterVentional Advances (VIVA) meeting in Las Vegas. Data presented included a 12-month
interim analysis from the RANGER II SFA trial of the Ranger™
Drug-Coated Balloon (DCB) as well as 24-month results from the
IMPERIAL trial of the Eluvia™ Drug-Eluting Vascular Stent (DES),
which exhibited the highest 24-month primary patency reported to
date for the treatment of femoropopliteal disease in a U.S. pivotal
trial with a DCB or DES.i
The RANGER II SFA study evaluated the safety and effectiveness
of the Ranger DCB, which has a low drug dose density of paclitaxel,
versus 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).
In the trial, the Ranger DCB exhibited a primary patency rate –
a measure of the target vessel remaining unobstructed at 12 months
– of 89.2% compared to 72.9% percent in patients treated with
standard PTA (p=0.0022), by Kaplan
Meier estimate. Additional key findings from the trial
include:
- Patients treated with the Ranger DCB had a significantly lower
target lesion revascularization (TLR) rate of 6%, in contrast to
17.9% observed with standard PTA (p=0.0018), substantially reducing
the patient's need for repeat procedures at 12 months;
- No difference in all-cause mortality at 12 months with a 2.3%
rate for the patients treated with Ranger DCB vs. 2.5% in patients
treated with standard PTA (p>.99);
- Data from the Pharmacokinetics (PK) sub-study showed that
11 of 12 patients with an average lesion length of 154.2mm had
unmeasurable paclitaxel levels in venous plasma approximately one
hour after DCB deployment and removal.
"These excellent clinical data coupled with the ease of
deliverability of the Ranger DCB are reassuring for physicians as
we evaluate the most appropriate therapies based on individual
patient needs," said Ravish Sachar, MD, University of North Carolina - Rex Hospital
Physician-in-Chief for Heart and Vascular services and principal
investigator of the RANGER II SFA trial. "The high primary patency
rate as well as the significantly lower TLR rate, which reduces the
need for repeat procedures, are very encouraging."
Also presented at the meeting was a 24-month analysis of data
from the IMPERIAL trial, which evaluated the Eluvia stent versus
the Zilver® PTX® Drug-Eluting Peripheral
Stent for the treatment of patients with symptomatic PAD that had
SFA and PPA lesions up to 140mm in length. The Eluvia stent
utilizes a drug-polymer combination and offers controlled delivery
and sustained release of the lowest dose of paclitaxel of any
peripheral drug-eluting device. In the study, the Eluvia stent
exhibited a primary patency rate of 83.0% versus 77.1% with Zilver
PTX, by Kaplan Meier estimate, the
highest 24-month primary patency reported to date for the treatment
of femoropopliteal disease in a U.S. pivotal trial with a DCB or
DES.i The analysis also confirmed:
- Statistically significant lower clinically-driven TLR rate of
12.7% for patients treated with the Eluvia stent, in contrast to
20.1% observed within the Zilver PTX cohort (p=0.0495), thus
reducing the need for repeat procedures at 24 months;
- A low all-cause mortality rate of 7.1% for the Eluvia stent and
8.3% for those treated with the Zilver PTX (p=0.6649), which is
within range expected for symptomatic peripheral arterial
disease.ii
"We are very pleased with the safety and efficacy demonstrated
by the Ranger DCB and the Eluvia stent, both of which showed
exceptional durability while preventing repeat TLRs in 66% and 40%
of treated patients, respectively," said Ian Meredith, M.D., executive vice president and
global chief medical officer, Boston Scientific. "The excellent
outcomes presented today underscore our commitment to physicians
and their patients with PAD. We continue to drive innovation in the
drug-eluting vascular space and these results add to the growing
body of evidence supporting our therapy options for the treatment
of this challenging disease."
The RANGER DCB gained CE Mark in 2014 and the company submitted
for U.S. Food and Drug Administration approval of the device
earlier this year. The combination of the RANGER DCB as well as the
Eluvia stent positions Boston Scientific as the only company to
have both a DES and a DCB for the treatment of PAD in their
portfolio.
In the U.S., the Ranger DCB is an investigational device and is
not available for sale.
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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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
i
Highest-two year primary patency based on 24-month Kaplan-Meier
estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II
and Primary Randomization for Zilver PTX
RCT.
|
ii Feringa HH, Bax JJ, Hoeks S, et
al. A prognostic risk index for long-term mortality in patients
with peripheral arterial disease. Arch Intern Med.
2007;167:2482-2489.
|
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SOURCE Boston Scientific Corporation