Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, today announced the first patient
enrolled in the latest Barrigel™ rectal spacer randomized,
controlled, single-blinded multicenter study: The PPRT Trial.
Barrigel™ rectal spacer is the first and only sculptable
hyaluronic acid rectal spacer designed to significantly reduce
radiation that reaches the rectum during prostate radiation
therapy.1-3 This new study will evaluate Barrigel™ rectal spacer in
patients undergoing hypofractionated post-prostatectomy radiation
therapy across sites in the U.S. and one site in Australia.“Our
first enrolled patient represents a significant milestone as we
grow our body of clinical evidence for Barrigel™ rectal spacer with
patients undergoing radiation therapy after a prior prostatectomy,”
said Martin T. King, MD, PhD, Radiation Oncologist with the
Dana-Farber Brigham Cancer Center, Harvard Medical School Assistant
Professor of Radiation Oncology, and principal investigator of the
study.* “Our study endpoints are to demonstrate Barrigel™ rectal
spacer as a safe and effective option that reduces prostate
radiation side effects for this patient population.”
Based on the segmentation of risk groups between low, medium and
high, prostate cancer reoccurrence after radical prostatectomy
ranges from 16 to 46 percent.4
Rectal spacers are used during prostate cancer radiation therapy
to enable effective radiation dosage to the prostate while sparing
healthy rectal tissue. This is especially important in
hypofractionated treatment regimens, in which radiation is
delivered at higher doses over a fewer number of treatment
sessions. Unlike other rectal spacers made from different
materials, which harden almost immediately after administration,
the hyaluronic acid in Barrigel™ rectal spacer remains soft
and pliable. This gives physicians time to sculpt, layer, and add
more Barrigel™ rectal spacer as needed to optimize rectal
protection.1,5-7 Additionally, Barrigel™ rectal spacer is
highly visible in real time using transrectal ultrasound, which
helps to ensure optimal spacing.1,5-7
“Scientific evidence serves as the cornerstone for the
advancement and expansion of medical technologies, fostering trust
between clinicians and patients,” stated Michael Chao, MD, a
Radiation Oncologist at the Olivia Newton John Cancer Wellness
& Research Centre in Victoria, Australia.* “I take great pride
in being the first physician to treat a patient in this clinical
trial.”
Study sites will enroll patients who have:
- Undergone nerve-sparing
prostatectomy (intrafascial)
- No radiographic evidence of local,
regional, or distant metastatic disease via (PSMA) PET imaging
- An intact facial layer to support
the Barrigel™ rectal spacer
- Had six months of androgen
deprivation therapy, a first-line treatment for advanced prostate
cancer
About Barrigel™ Rectal
SpacerBarrigel™ rectal spacer is the first and only
hyaluronic acid rectal spacer that separates the prostate from the
rectum to protect the rectum during radiation therapy treatment for
prostate cancer.1 Barrigel™ rectal spacer is made from
Non-Animal Stabilized Hyaluronic Acid (NASHA).8
Hyaluronic acid is a substance naturally present in the human
body and is highly biocompatible and fully absorbable. NASHA has a
proven history of safety and efficacy in a wide variety of medical
applications in men, women and children worldwide.5,9
Barrigel™ rectal spacer has been proven to significantly
reduce unwanted side effects from prostate cancer radiation therapy
and is approved for rectal spacing in the United States, Australia,
and Europe. Barrigel™ rectal spacer can be used for prostate
cancer patients with T1-T3b disease. For more information
about Barrigel™ rectal spacer, please
visit https://barrigel.com/hcp/barrigel-control-matters.
Barrigel™ Rectal Spacer Important Safety
InformationBarrigel™ rectal spacer is intended to
temporarily position the anterior rectal wall away from the
prostate during radiotherapy for prostate cancer and, in creating
this space, it is the intent of Barrigel™ rectal spacer to reduce
the radiation dose delivered to the anterior rectum. Barrigel™
rectal spacer is composed of biodegradable material and maintains
space for the entire course of prostate radiotherapy treatment and
is intended to be absorbed by the patient’s body over time.
Barrigel™ rectal spacer should only be administered by qualified
and properly trained physicians with experience in ultrasound
guidance and injection techniques in the urogenital/pelvic
area.
As with any medical treatment, there are some risks involved
with the use of Barrigel™ rectal spacer. Potential complications
associated with the use of Barrigel™ rectal spacer include, but are
not limited to: pain associated with Barrigel™ rectal spacer
injection; needle penetration of the bladder, prostate, rectal
wall, rectum, or urethra; injection of Barrigel™ rectal spacer into
the bladder, prostate, rectal wall, rectum, urethra, or
intravascularly; local inflammatory reactions; infection; urinary
retention; rectal mucosal damage, ulcers, necrosis; bleeding;
constipation; and rectal urgency. More information on indications,
contraindications, warnings and instructions for use can be found
in the Instructions For Use at www.barrigel.com.
Caution: Federal (USA) law restricts this device to sale by or
on the order of a physician.
*Martin T. King and Michael Chao are paid consultants of
Teleflex.
About Teleflex IncorporatedAs a global provider
of medical technologies, Teleflex is driven by our purpose to
improve the health and quality of people’s lives. Through our
vision to become the most trusted partner in healthcare, we offer a
diverse portfolio with solutions in the therapy areas of
anesthesia, emergency medicine, interventional cardiology and
radiology, surgical, vascular access, and urology. We believe that
the potential of great people, purpose driven innovation, and
world-class products can shape the future direction of
healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™,
Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands
united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For
more information, please visit teleflex.com.
Forward-Looking StatementsAny statements
contained in this press release that do not describe historical
facts may constitute forward-looking statements. Any
forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which
may cause actual results or company actions to differ materially
from what is expressed or implied by these statements. These risks
and uncertainties are identified and described in more detail in
our filings with the Securities and Exchange Commission, including
our Annual Report on Form 10-K.
Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA,
Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or
registered trademarks of Teleflex Incorporated or its affiliates,
in the U.S. and/or other countries.© 2024 Teleflex Incorporated.
All rights reserved.
References:
- Mariados NF, Orio PF, Schiffman Z,
et al. Hyaluronic acid spacer for hypofractionated prostate
radiation therapy: a randomized clinical trial. JAMA Oncol. 2023;
e1-e8.**
- King MT, Svatos M, Orio PF III et
al. Evaluating the Quality-of-Life Effect of Apical Spacing with
Hyaluronic Acid Prior to Hypofractionated Prostate Radiation
Therapy: A Secondary Analysis, Pract Radiat Oncol. 2023;e1-e6.
(Study sponsored by Palette Life Sciences, now part of
Teleflex).**
- Data on File. As of 06/01/2024.
- Falagario UG et al. Biochemical
Recurrence and Risk of Mortality Following Radiotherapy or Radical
Prostatectomy. JAMA Netw Open (2023).
- Svatos M, Chell E,
Low DA, et al. Symmetry, separation, and stability: Physical
properties for effective dosimetric space with a stabilized
hyaluronic acid spacer. Med Phys. 2024;
1-15. https://doi.org/10.1002/mp.17292**
- Gejerman G,
Goldstein MM, Chao M et al. Barrigel spacer injection technique.
Pract Radiat Oncol. 2023:e1-e5. (Drs Gejerman, Chao, Lederer, and
Orio are paid consultants of Palette Life Sciences, now part of
Teleflex).
- Williams J, Mc
Millan K, Chao M et al. Hyaluronic acid rectal spacer in EBRT:
Usability, safety and symmetry related to user experience. J
Med Imag Radiat Sci (2022).
- Barrigel Injectable
Gel Instructions for Use (2022).
- Restylane® celebrates 25 years
of natural-looking results with its signature line of hyaluronic
acid fillers. 2021. Available
at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html.
Accessed Sept 30, 2021.
**Study sponsored by Palette Life Sciences, now part of
Teleflex.
Contacts:TeleflexLawrence KeuschVice President,
Investor Relations and Strategy
Developmentinvestor.relations@teleflex.com610-948-2836
Media Contact:Glenn SilverPartner National Media Relations
Specialistglenn.silver@finnpartners.com646-871-8485
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