Surmodics Provides Update Regarding TRANSCEND Clinical Trial
April 17 2019 - 11:00AM
Business Wire
Surmodics, Inc. (NASDAQ: SRDX), a leading provider of medical
device and in vitro diagnostic technologies to the healthcare
industry, has resumed patient enrollment into its TRANSCEND
clinical trial and is nearly 75 percent of the way to its goal of
446 randomized patients.
Patient enrollment in TRANSCEND, the pivotal clinical trial for
the SurVeil™ drug-coated balloon (DCB), was temporarily paused
following the March 15 publication of a Food & Drug
Administration (FDA) letter to physicians. The letter included an
update on the Agency’s preliminary analysis of a potentially
concerning signal of increased long-term mortality with
paclitaxel-coated devices and recommended that physicians consider
alternative treatment methods until additional analysis has been
performed.
“Immediately following publication of the March 15 FDA
communication, we reached out to the Agency seeking guidance on the
recommendations and the impact on TRANSCEND,” said Gary Maharaj,
Surmodics President and CEO. “Following multiple conversations,
we’ve taken several actions in response to the Agency’s
recommendations, including updates to investigator communications,
patient Informed Consent Forms (ICF), and data safety review and
patient follow-up procedures. A number of our trial sites have
already secured IRB or Ethics Committee approval of the updated ICF
and are actively enrolling and randomizing patients.”
FDA Recommendations: Surmodics
Action: Follow device recommendations from March 15
letter Communicated FDA recommendations to trial investigators
Update patient informed consent form (ICF) Initiated process
to update ICF at sites worldwide Include ongoing independent
Data Safety Monitoring Board (DSMB) review Ongoing Clinical Events
Committee (CEC) and DSMB reviews were initiated at trial onset
Take measures to increase follow-up with patients
Establishing an aggressive patient follow-up program for both new
patient randomizations and those already treated
The TRANSCEND randomized trial will evaluate the SurVeil DCB for
treatment of peripheral artery disease (PAD) in the upper leg
compared to a commercially available DCB treatment. The results of
the trial will also include long-term, patient-level data out to 5
years. The Company continues to assess the impact of the March 15
FDA communication on its expectations regarding the timing of
completion of patient enrollment in the TRANSCEND clinical trial
and related regulatory approvals for the SurVeil DCB.
“Patient safety is the top priority in every study, so pausing
trial enrollment while implementing the recommendations from the
FDA was in the best interest of both our patients and this trial,”
said William Gray, MD, the national Co-Principal Investigator of
the TRANSCEND study. “We’re pleased to see many sites
enthusiastically resuming enrollments. The TRANSCEND trial comes at
a critical time in the endovascular field and will provide
important safety and efficacy data for the next generation SurVeil
DCB as it compares to the Medtronic IN.Pact® DCB and will
ultimately be useful for physicians and the patients that they
treat.”
Worldwide, over 200 million people have PAD, 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. 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.
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 immunoassay
tests and microarrays. Surmodics is pursuing highly differentiated
whole-product solutions that are designed to address unmet clinical
needs for its medical device customers and engineered to the most
demanding requirements. This key growth strategy leverages the
combination of the Company’s expertise in proprietary surface
technologies, along with enhanced device design, development and
manufacturing capabilities. The Company mission remains to improve
the detection and treatment of disease. Surmodics is headquartered
in Eden Prairie, Minnesota. For more information, 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 are
forward-looking statements, including statements and beliefs about
the TRANSCEND clinical trial and the SurVeil DCB. Forward-looking
statements involve inherent risks and uncertainties, and important
factors could cause actual results to differ materially from those
anticipated, including 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, 2018, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190417005512/en/
Surmodics, Inc.Tim Arens, 952-500-7000ir@surmodics.com
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