- Study compares SurVeil™ DCB to
Medtronic IN.PACT® Admiral® DCB
- SurVeil DCB design includes new
proprietary coating for interventional treatment of PAD
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical
device and in vitro diagnostic technologies, today announced it has
received an investigational device exemption (IDE) from the U.S.
Food and Drug Administration (FDA) to initiate a pivotal clinical
trial of 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 the Medtronic
IN.PACT® Admiral® DCB.
The SurVeil DCB pivotal trial will be among the first trials in
the U.S. to compare a next-generation DCB with a
commercially-available DCB.
“By providing a head-to-head comparison with today’s
market-leading DCB, the TRANSCEND trial will answer clinically
important questions about the relative performance of DCBs,” said
Gary Ansel, MD, system medical chief of the Vascular Program at
OhioHealth. “DCB therapy for patients with lower extremity PAD is
growing rapidly, and while results have been encouraging there is
significant room for improvement.”
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
concentrations compared to control DCBs.1
“Surmodics’ expertise and capabilities in surface technology are
evident in the design and pre-clinical performance of the SurVeil
DCB,” said Kenneth Rosenfield, MD, Section head, Vascular Medicine
and Intervention at Massachusetts General Hospital and chair of the
Surmodics clinical advisory board. “We’re excited about Surmodics’
capability to improve on the performance of existing DCBs.”
The SurVeil DCB early feasibility study (EFS), conducted in the
U.S., met its primary endpoint by demonstrating peak paclitaxel
plasma concentrations post-index procedure. Consistent with
pre-clinical data, systemic levels were low and cleared rapidly. No
safety issues attributed to the product have been reported.
“Surmodics’ decision to pursue the EFS in the U.S. demonstrated
our confidence in the device and we are excited to be moving this
into the pivotal trial,” said Gary Maharaj, president and CEO of
Surmodics. “The next-generation technology in the SurVeil DCB aims
to improve drug transfer and effect on the arterial wall with a
lower drug dose and a reduction in the amount of drug reaching
tissue outside the area of treatment. We have been extremely
satisfied with our pre-clinical and EFS results and look forward to
working with our investigators in this trial to further evaluate
the safety and efficacy compared to standard-of-care DCB
therapy.”
The development of the SurVeil DCB is a major step forward in
Surmodics’ strategy to transform from a surface modification
technology company to a provider of whole-product solutions for its
medical device customers. In 2015, the company acquired Creagh
Medical, an innovative developer and manufacturer of balloon
catheters located in Ireland, and U.S.-based NorMedix, a
manufacturer of differentiated specialty catheter and device
delivery systems. Surmodics now has complete capabilities for
design, development and high-volume manufacturing of a wide variety
of highly differentiated balloon catheter solutions that utilize
the company’s advanced surface technology.
About the SurVeil DCB 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 trial will enroll up to 446 subjects at approximately 60
sites in the U.S. and 18 outside the U.S. Study participants will
be randomized to receive either treatment with SurVeil DCB or
IN.PACT Admiral DCB. 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 36 months post-index procedure. Surmodics
expects to initiate enrollment in the TRANSCEND clinical trial in
the fourth quarter of calendar 2017.
The trial will be led by national co-principal investigators
Kenneth Rosenfield, MD, Section Head, Vascular Medicine and
Intervention at Massachusetts General Hospital, and Gary Ansel, MD,
System Medical Chief of the Vascular Program at OhioHealth.
Marianne Brodmann, MD, 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 in the U.S. 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 company’s
strategy to transform to a provider of whole-product solutions, and
the timing, 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
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.
1 Surmodics data on file2 Fowkes FGR, et al. Lancet 2013,
382(9901):1329-1340.3 Centers for Disease Control and Prevention.
Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.4 National
Institutes of Health. What is Peripheral Artery Disease? n.d.
Web.
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version on businesswire.com: http://www.businesswire.com/news/home/20170726005415/en/
Surmodics, Inc.Andy LaFrence, 952-500-7000ir@surmodics.com
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