Comparing SurVeil® DCB to Medtronic IN.PACT®
Admiral® DCB
Plan to enroll up to 446 patients at approximately 78 sites
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Oct. 23, 2017--
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and
in vitro diagnostic technologies, today announced enrollment of the
first patient in TRANSCEND, the pivotal clinical trial for the SurVeil®
drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil
DCB for treatment for peripheral artery disease (PAD) in the upper leg
compared to a commercially available DCB treatment. Up to 446 patients
will be randomized 1:1 to receive either the SurVeil DCB or
Medtronic’s IN.PACT® Admiral® DCB at approximately 60 U.S. sites and 18
sites outside the United States.
“Based on the preclinical and early feasibility study results we have
seen so far, I am excited about the potential of the Surveil DCB
as a third-generation DCB to improve the treatment of PAD,” said Kenneth
Rosenfield, M.D., section head, Vascular Medicine and Intervention at
Massachusetts General Hospital, chair of the Surmodics Clinical Advisory
Board and U.S. co-principal investigator for the TRANSCEND
trial. “TRANSCEND will be a rigorous Level One trial that will answer
important questions about DCB technologies.”
The design of the Surveil DCB reflects Surmodics’ long-standing
industry leadership in the development of surface technology for
vascular medical devices. The device includes a proprietary
drug-excipient formulation for the balloon coating and is manufactured
using a proprietary process to improve coating uniformity. Pre-clinical
data have shown a three to five times higher target tissue drug
concentration, a more evenly distributed and durable drug effect, and
lower incidence of downstream drug particles compared to control DCBs.1
“This is a major step in the right direction for Surmodics, as we apply
and evaluate our unique technology with the goal of improving clinical
outcomes for patients with peripheral artery disease,” said Gary
Maharaj, president and CEO of Surmodics. “We’re thrilled to be underway
with TRANSCEND and look forward to working with our investigators to
execute an efficient and rigorous pivotal trial.”
About the TRANSCEND Pivotal Trial
The objective of the Surveil DCB pivotal trial, TRANSCEND, is to
evaluate the safety and effectiveness of the device for treatment of
subjects with symptomatic PAD due to stenosis of the femoral and/or
popliteal arteries. The clinical study will be used to support
regulatory approvals (U.S. and Europe) and reimbursement. The primary
efficacy endpoint of the trial is primary patency, defined as a
composite of freedom from restenosis and clinically-driven target lesion
revascularization (TLR) through 12 months post-index procedure. All
randomized subjects will be followed through 60 months post-index
procedure.
The trial will be led by national co-principal investigators Kenneth
Rosenfield, M.D., and Gary Ansel, M.D., system medical chief of the
Vascular Program at OhioHealth. Marianne Brodmann, M.D., substitute head
of the Division of Angiology, Department of Internal Medicine, Medical
University of Graz, Graz, Austria, is the European principal
investigator.
The Surveil DCB is not available for sale anywhere in the world,
and is for investigational use only.
About Peripheral Artery Disease
Worldwide, over 200 million people have PAD,2 a serious and
underdiagnosed circulatory condition caused by build-up of arterial
plaque, most commonly in the legs. Twelve to 20 percent of Americans
over 60 years old have PAD.3 PAD increases risk of coronary
artery disease, heart attack and stroke, and can impair the ability to
walk. If left untreated, PAD can lead to gangrene and limb amputation.4
About Surmodics, Inc.
Surmodics is the global leader in surface modification technologies for
intravascular medical devices and a leading provider of chemical
components for in vitro diagnostic (IVD) tests and microarrays.
Following two recent acquisitions of Creagh Medical and NorMedix, the
Company is executing a key growth strategy for its medical device
business by expanding to offer total intravascular product solutions to
its medical device customers. The combination of proprietary surface
technologies, along with enhanced device design, development and
manufacturing capabilities, enables Surmodics to significantly increase
the value it offers with highly differentiated intravascular solutions
designed and engineered to meet the most demanding requirements. With
this focus on offering total solutions, Surmodics’ mission remains to
improve the detection and treatment of disease. Surmodics is
headquartered in Eden Prairie, Minnesota. For more information about the
company, visit www.surmodics.com.
The content of Surmodics’ website is not part of this press release or
part of any filings that the company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that
are not historical or current facts, including statements about beliefs
and expectations regarding the impact and success of the clinical
evaluation of the Surveil DCB, are forward-looking
statements. Forward-looking statements involve inherent risks and
uncertainties, and important factors could cause actual results to
differ materially from those anticipated, including (1) our ability to
successfully, and in a timely fashion, develop, obtain regulatory
approval for, and commercialize our Surveil DCB, and other
proprietary products; (2) our ability to achieve expected benefits from
our acquisitions; (3) possible adverse market conditions and possible
adverse impacts on our cash flows, and (4) the factors identified under
“Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for
the fiscal year ended September 30, 2016, and updated in our subsequent
reports filed with the SEC. These reports are available in the Investors
section of our website at www.surmodics.com and
at the SEC website at www.sec.gov.
Forward-looking statements speak only as of the date they are made, and
we undertake no obligation to update them in light of new information or
future events.
1Surmodics data on file
2 Fowkes FGR, et al. Lancet
2013, 382(9901):1329-1340.
3Centers for Disease Control
and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4National Institutes of Health. What is Peripheral Artery Disease? n.d.
Web.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171023005341/en/
Source: Surmodics, Inc.
Surmodics, Inc.
Andy LaFrence, 952-500-7000
ir@surmodics.com
