Six-Month Data from the Surmodics SurVeil® Drug-Coated Balloon Early Feasibility Study Presented at VIVA 2017
September 13 2017 - 7:06PM
Business Wire
- Study met primary endpoint and
six-month secondary safety endpoints
- Results demonstrated primary patency of
100% and significant improvement in measured clinical outcomes
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical
device and in vitro diagnostic technologies, today announced that
data from the PREVEIL early feasibility study (EFS) of the
company’s SurVeil® drug-coated balloon (DCB) was shared in a
late-breaking clinical trial presentation at the Vascular
Interventional Advances (VIVA) 2017 conference in Las Vegas.
PREVEIL is a prospective, U.S., multi-center, single-arm trial
designed to assess the safety and feasibility of the SurVeil DCB in
the treatment of subjects with symptomatic peripheral artery
disease (PAD) due to de novo lesions of the femoral and popliteal
arteries.
Gary Ansel, MD, system medical chief of the Vascular Program at
OhioHealth, presented six-month results from 13 patients
(Rutherford class 2 to 4) at 3 clinical sites who were treated with
the SurVeil DCB. Average lesion length was 56 mm. Clinical
assessments included primary patency and late lumen loss through
six months, plasma paclitaxel levels, and changes in Rutherford
classification, resting ankle brachial index/toe brachial index
(ABI/TBI), 6-minute walk test, and walking impairment questionnaire
(WIQ) at 1, 6, 12, 24 and 36 months. Key secondary safety endpoints
included freedom from major vascular complications, evidence of
paclitaxel toxicity, or thrombolysis in myocardial infarction
(TIMI).
Data from the study show that acute success measures of safety
were achieved in 100 percent of subjects. Results also showed
primary patency of 100 percent and mean late lumen loss of
0.27±0.54 mm at six months. Significant improvement in Rutherford
classification, ABI/TBI, 6-minute walk test, and WIQ were seen at
30 days and six months. Median paclitaxel plasma concentration
peaked immediately post-procedure (Cmax 1.07 ng/mL) and was
undetectable at 30 days. Secondary technical, device, and procedure
success criteria were achieved.
“We are encouraged by the early patient data using the Surmodics
SurVeil DCB platform and are excited to continue clinical
evaluation of the product in the U.S. pivotal trial,” said Dr.
Ansel, who is a principal investigator in both the PREVEIL trial
and the SurVeil DCB pivotal trial, TRANSCEND.
“Our goal with the SurVeil DCB is 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,” said Gary Maharaj, president and CEO of Surmodics. “We
are very satisfied with the results of the EFS and believe they are
consistent with our encouraging pre-clinical data.”
About the Surmodics SurVeil® DCB
In July 2017, Surmodics received an investigational device
exemption (IDE) from the U.S. Food and Drug Administration (FDA) to
initiate a pivotal clinical trial of the SurVeil DCB. The
randomized trial, TRANSCEND, will evaluate the SurVeil DCB for
treatment for PAD in the upper leg compared to the Medtronic
IN.PACT® Admiral® DCB. Surmodics expects to initiate enrollment in
the TRANSCEND clinical trial in the fourth quarter of calendar
2017.
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
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 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 SurVeil DCB and TRANSCEND clinical trial, including the
expected initiation of that trial, 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; and (3) 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 file
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Surmodics, Inc.Andy LaFrence, 952-500-7000Vice President
of Finance, Information Systems and Chief Financial Officer
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