Surmodics Announces TRANSCEND Trial 36-Month Data Presented at 50th Annual VEITH Symposium
16 November 2023 - 1:30PM
Business Wire
Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical
device and in vitro diagnostic technologies to the health care
industry, today announced that 36-month data from its TRANSCEND
clinical trial was presented by Dr. Peter A. Schneider at the 50th
Annual VEITH Symposium in New York, New York.
The TRANSCEND trial is a prospective, multi-center,
single-blind, randomized, controlled trial to assess the safety and
efficacy of the SurVeil™ drug coated balloon (DCB) versus the
IN.PACT® Admiral® DCB for treatment of superficial femoral and
proximal popliteal artery lesions. A total of 446 patients were
randomized to either the low-dose paclitaxel (2.0 µg/mm2) SurVeil
DCB (n = 222) or the high-dose (3.5 µg/mm2) paclitaxel IN.PACT
Admiral DCB (n = 224) at 65 sites in the United States, Australia,
Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New
Zealand.
The primary efficacy endpoint is 12-month primary patency,
defined as freedom from binary restenosis or clinically driven
target lesion revascularization (CD-TLR). Primary patency was
comparable between the SurVeil DCB and IN.PACT Admiral (82.2% vs
85.9%). The primary safety endpoint is freedom from device or
procedure related death within 30 days and above-ankle amputation
or CD-TVR within 12 months, which also demonstrated comparable
outcomes between SurVeil DCB and IN.PACT Admiral DCB (91.8% vs
89.9%). Non-inferiority was tested using a multiple imputation
approach at one-sided alpha 0.025.
Data demonstrates the SurVeil DCB is non-inferior to the IN.PACT
Admiral DCB with regards to both safety and efficacy, while
delivering a substantially lower drug dose. Both the SurVeil and
IN.PACT Admiral DCBs utilize coatings with the anti-proliferative
drug paclitaxel. However, the IN.PACT Admiral DCB has a 75% higher
drug load of paclitaxel (3.5 μg/mm2) than the SurVeil DCB, which
has a 2.0 μg/mm² drug load.
Patient outcomes are being collected at 1, 6, 12, 24, 36, 48,
and 60 months. Intermediate-term (36-month) secondary outcomes
included clinically driven target lesion revascularization
(CD-TLR), major target limb amputation (TLA), thrombosis at the
target lesion, and historical major adverse events.
A total of 352/363 (96.97%) patients completed their 36-month
visit.
The SurVeil DCB, which previously demonstrated noninferior
primary safety and effectiveness outcomes through 12 months with a
lower paclitaxel dose, continues to demonstrate similar outcomes at
intermediate-term follow-up of 36 months compared with the
high-dose IN.PACT Admiral DCB in the treatment of patients with
symptomatic peripheral artery disease (PAD) caused by stenosis of
the femoral and/or popliteal arteries. Results at 36 months for
SurVeil versus IN.PACT Admiral were statistically comparable,
including CD-TLR (20.3% vs 19.5%; P =0.897), major TLA (0.0% vs
0.5%; P = 1.000), thrombosis at the target lesion (0.6% vs 0.0%; P
= .475), and historical MAEs (28.6% vs 28.5%; P = 1.000).
“The TRANSCEND 36-Month data continues to demonstrate safe and
effective performance of the SurVeil DCB. SurVeil DCB is a
best-in-class, high-quality treatment option for our PAD patients
utilizing a next generation surface coating with a lower dose of
Paclitaxel compared to IN.PACT Admiral DCB,” said Dr. Peter A.
Schneider.
About the SurVeil DCB The SurVeil DCB, a next-generation
device that utilizes best-in-class technology in the treatment of
peripheral artery disease (PAD), includes a proprietary
drug-excipient formulation for a durable balloon coating and is
manufactured using an innovative process to improve coating
uniformity. The SurVeil DCB received CE Mark Certification in the
European Union in June 2020 and received FDA approval in the United
States in June 2023.
In February 2018, Surmodics entered into an agreement with
Abbott (NYSE: ABT) that provided Abbott with exclusive worldwide
commercialization rights for the SurVeil DCB. With U.S. regulatory
approval of the device, Surmodics will retain responsibility for
manufacturing commercial quantities of the product and will realize
revenue from product sales to Abbott as well as a share of profits
resulting from sales to third parties.
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) immunoassay tests and microarrays. Surmodics is
pursuing highly differentiated medical devices that are designed to
address unmet clinical needs 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, including statements about future
collection of data in the TRANSCEND clinical trial, the potential
clinical uses of the SurVeil DCB, Surmodics’ potential
responsibilities and revenues, and the company’s growth strategy,
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 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, 2022, and updated in our subsequent reports filed
with the SEC. These reports are available in the Investors section
of our website at https://surmodics.gcs-web.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/20231116865910/en/
Surmodics Investor Inquiries Jack Powell, Investor Relations
ir@surmodics.com
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