Surmodics Announces SWING Trial 24-Month Data to be Presented at VEITH Symposium on November 15
07 Noviembre 2023 - 6:30AM
Business Wire
35-subject SWING Trial evaluates the safety, performance of
Surmodics’ Sundance™ Sirolimus Drug-Coated Balloon
Updated safety and performance data for the SWING trial 24-month
data will be shared
Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical
device and in vitro diagnostic technologies to the health care
industry, announced today that Professor Ramon Varcoe will present
24-month data from the SWING Trial, a first-in-human study of the
safety and performance of the Sundance™ Sirolimus Drug-Coated
Balloon (DCB). The session will be held on Wednesday, November
15th, at the 50th annual VEITH Symposium in New York, New York.
TITLE: 2-Year Results With The Sundance DCB (Surmodics)
To Treat BTK Occlusive Lesions: From The SWING Trial DATE:
Wednesday, November 15 TIME: 9:18 – 9:23 AM (EST)
VENUE: New York Hilton Midtown, Grand Ballroom East, 3rd
Floor
Professor Varcoe, MBBS, MS, FRACS, PHD, MMed (ClinEpi), co-lead
investigator of the SWING Trial, is a vascular surgeon at Sydney’s
Prince of Wales and Prince of Wales Hospital where he is Director
of Operating Theatres, and Director of Surgery and Anesthetics for
the South East Sydney Health District. He will review safety and
performance data collected through 24 months of follow-up for 35
subjects with occlusive disease of the infra-popliteal arteries who
were treated at study sites in Australia, New Zealand, and
locations in Europe. Study subjects will be followed for 36 months
after the index procedure.
Professor Varcoe previously presented SWING Trial 12-month data
on January 18th at the 35th Annual International Symposium on
Endovascular Therapy (ISET) conference. An 8.3% rate of major
adverse events was reported in the per protocol (PP) population
(two clinically driven target limb revascularizations) at 6 months,
with no additional adverse events reported for PP subjects in the
12-month data. Target lesion primary patency rate, defined as
freedom from target vessel occlusion or target lesion
revascularization associated with deterioration or Rutherford
Clinical Classification and/or increase in size of pre-existing
wounds (or occurrence of new wounds), and lesion restenosis
>50%, was 80% at 12 months in the PP population.
The Sundance Sirolimus Drug-Coated Balloon utilizes a
next-generation coating technology consisting of microcrystalline
sirolimus and a proprietary excipient designed to maximize drug
transfer, enhancing sirolimus delivery and sustaining therapeutic
levels in the artery. Sirolimus, a potent anti-inflammatory and
anti-proliferative compound, has been used successfully in coronary
drug-eluting stents. The delivery of sirolimus to the vessel wall
during mechanical balloon dilatation provides an ancillary action
of inhibiting the proliferation of cells, with the intended purpose
of reducing restenosis. The Sundance Sirolimus Drug-Coated Balloon
is not available for sale anywhere in the world, and currently is
for investigational use only.
About Surmodics, Inc.
Surmodics is a leading provider of performance coating
technologies for intravascular medical devices and chemical and
biological components for in vitro diagnostic immunoassay tests and
microarrays. Surmodics also develops and commercializes highly
differentiated vascular intervention 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
modification and drug-delivery coating technologies, along with its
device design, development and manufacturing capabilities. The
Company’s mission is 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 beliefs and expectations regarding the Sundance™
Sirolimus Drug-Coated Balloon, 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 drug-coated balloon products; and (2) 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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231107560392/en/
Surmodics Investor Inquiries Jack Powell, Investor Relations
ir@surmodics.com
SurModics (NASDAQ:SRDX)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
SurModics (NASDAQ:SRDX)
Gráfica de Acción Histórica
De May 2023 a May 2024