Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, today announced the presentation of data
supporting the safety and efficacy of Barrigel™ rectal spacer,
the first and only sculptable hyaluronic acid rectal spacer. It
is designed to significantly reduce radiation that reaches the
rectum during prostate cancer radiation therapy.1-3 The data were
presented in three abstracts5-7 at the American Society for
Radiation Oncology (ASTRO) 2024 Annual Meeting, which took place in
Washington, DC, September 29 to October 2, 2024.
Rectal spacers are used during prostate cancer radiation therapy
to enable effective radiation dosing 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.1,8-10 Additionally, Barrigel™ rectal spacer is highly
visible in real time using transrectal ultrasound, which helps to
ensure optimal spacing.1,8-10
Approximately 300,000 men will be diagnosed with prostate cancer
this year in the U.S. alone. The incidence rate has increased by 3%
per year overall over the past decade.11
“Building on the safety and efficacy of Barrigel™ rectal spacer
previously proven in a randomized clinical trial,1 the data
presented at ASTRO 2024 demonstrate that excellent outcomes can
also be achieved in real-world settings and in patients undergoing
repeat radiation therapy,” said Jacqueline Welch, Vice President of
Global Clinical and Scientific Operations at Teleflex. “They also
show that rare instances of unintended injection regions can be
reversed with hyaluronidase, a naturally occurring enzyme. This is
an important advantage over other rectal spacers, which cannot be
reversed following the initial procedure and require time for
biodegradation. Our ASTRO 2024 data underscore our ongoing
commitment to advancing outcomes for patients with malignant and
benign prostate conditions.”
Presented Abstracts
Impact of Hyaluronic Acid (HA) Rectal Spacer Quality
Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score on Rectal
Dosimetry and Acute and Late Gastrointestinal (GI) Toxicity
Outcomes – an Australian Experience (Abstract
#3222)7
This abstract reports retrospective data from 100 men undergoing
moderately fractionated EBRT (60Gy/62Gy in 20 fractions) for
localized prostate cancer using Barrigel™ rectal spacer in
Australia. Implants were assessed for quality (mSQS score),
symmetry (FV score), and RWI (rectal wall infiltration), and acute
and late gastrointestinal (GI) toxicity were also evaluated.
Excellent implant quality (mSQS score=1) was reported for 74
patients; 24 patients had a score of 2 and only 2 patients had a 0
score. Symmetrical rectal spacing (FV score=1) was achieved in 97%
of implants. Physicians deemed Barrigel™ rectal spacer very easy
(98%) or easy (2%) to implant. No acute or late GI toxicity >
Grade 2 was reported; 7 acute and 5 late Grade 1 toxicity events
were reported. RWI occurred in 1 patient and was reversed with
hyaluronidase with no subsequent adverse effects. Only 1 case of
regional prostate cancer recurrence has been reported with median
follow-up of 1.68 years.
Rectal Wall Infiltration (RWI) with Hyaluronic Acid
Based Rectal Spacer Reversal Protocol (Abstract
#3185)5
This abstract reports data from a retrospective analysis of
inadvertent RWI in 5,000 Australian men receiving Barrigel™ rectal
spacer for prostate cancer radiation therapy. Results of magnetic
resonance imaging (MRI) were used to identify RWI. Patients with
RWI were followed for the remainder of their radiation therapy and
for an additional 3 months following completion of radiation
therapy. The study identified 16 patients (0.32%) with RWI after
Barrigel™ rectal spacer insertion (Grade 1 by FV criteria n=5,
Grade 2 n=6, Grade 3 n=5), with a median volume of misplaced
Barrigel™ rectal spacer of 2.8 cc (total average Barrigel™ rectal
spacer volume was 9.2 cc). No post-procedural GI symptoms or acute
Grade 2+ GI toxicity were reported among these 16 men, and the
rectal mucosa was intact in the 12 men who underwent sigmoidoscopy.
Seven of the 16 men underwent Barrigel™ rectal spacer reversal
procedures with hyaluronidase, all of which were successful, and no
post-reversal complications were reported. The other 9 men were
monitored. No severe adverse complications (mucosal ulceration,
pelvic abscess, recto-prostatic fistula) have been reported among
the 16 men with RWI. The presence of RWI resulted in delayed
initiation of radiation therapy in 11 men (median delay = 3.2
months).
“These real-world, retrospective analyses offer further evidence
that Barrigel™ rectal spacer provides safe, effective, and
high-quality spacing in routine clinical practice,” said Michael
Chao, MD, a Radiation Oncologist at the Olivia Newton John Cancer
Wellness & Research Centre in Victoria, Australia, and author
on the two aforementioned abstracts.† “They also show that the
incidence of RWI with Barrigel™ rectal spacer is quite rare—only
0.32%—and that these rare cases can be reversed effectively with
hyaluronidase. Reversal is not feasible when RWI occurs with other
spacers because the inorganic materials of which they are made
cannot safely be dissolved in the body and must be absorbed over
time. This is another important benefit of Barrigel™ rectal spacer
that should be considered when selecting a rectal spacer for men
undergoing prostate cancer radiation therapy.”
Hyaluronic Acid Rectal Spacer in Locally Recurrent
Prostate Cancer with Prior Radiation Receiving SBRT: on
Feasibility, Safety, and Toxicity (Abstract
#3236)6
This abstract reports Barrigel™ rectal spacer safety, rectal
separation, ease of spacer placement, and treatment toxicity in 17
men undergoing repeat local radiation therapy for prostate cancer
using SRBT. There was a 100% success rate for Barrigel™ rectal
spacer placement, with no use of saline dissection and no adverse
events reported. Mean minimum separation between gross tumor volume
(GTV) and rectal tissue was 8.7 (± 5.6) mm, and adequate separation
was achieved in 86.4% of cases. No >Grade 1 GI toxicity or acute
Grade 3+ urinary toxicity were reported, and there was 1 case of
Grade 3 hemorrhagic cystitis (which the patient also experienced
during initial EBRT). Maximum point dose (Dmax) for radiation was
22.7 Gy (± 6.8), and the dose received by 30% (D30) and 60% (D60)
of the prostate was 6.8 Gy (±3.0), and 3.0 Gy (± 2.2),
respectively.
“Patients with local recurrence of prostate cancer treated
initially with EBRT (external beam radiation therapy) are often not
considered for repeat radiation therapy,” said LaToya McLean, MD, a
resident member at Thomas Jefferson University in Philadelphia,
Pennsylvania and lead author on the abstract. “A key reason for
this is concern about safely and effectively placing a rectal
spacer in tissue that has been previously irradiated, as this
tissue may be scarred or have adhesions that make it difficult to
separate. In this study, we show that Barrigel™ rectal spacer can
be used safely and effectively to achieve meaningful rectal
separation that allows patients with local prostate cancer
recurrence to receive radiation therapy while meeting dosimetric
constraints. I hope these findings will help reduce the barriers to
radiation therapy that these patients face.”
About Barrigel™ Rectal Spacer Barrigel™ 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 is made
from Non-Animal Stabilized Hyaluronic Acid (NASHA).12
Hyaluronic acid is a substance naturally present in the human
body and is highly compatible 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.8,13
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 is indicated 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 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 to reduce the radiation dose delivered to the anterior
rectum. Barrigel 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 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. Potential complications associated with
the use of Barrigel include, but are not limited to: pain
associated with Barrigel injection; needle penetration of the
bladder, prostate, rectal wall, rectum, or urethra; injection of
Barrigel 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.
† Michael Chao is a paid consultant 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, Titan SGS, UroLift and Weck are
trademarks or registered trademarks of Teleflex Incorporated or its
affiliates, in the U.S. and/or other countries. All other
trademarks are the property of their respective owners.
© 2024 Teleflex Incorporated. All rights reserved.
References:
- Mariados NF, Orio PF III, King MT 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.*
- Data on File. As of 06/01/2024.
- Hong A, Ischia J, Chao M. Case report: Reversal of hyaluronic
acid rectal wall infiltration with hyaluronidase. Front Oncol.
2022;12:870388.
- Hong A, Bolton D, Ramani S et al. Rectal wall infiltration with
hyaluronic acid based rectal spacer reversal protocol. Abstract
#3185. Presented at ASTRO 2024 October 1, 2024.
- McLean L, et al. Hyaluronic Acid Rectal Spacer in Locally
Recurrent Prostate Cancer with Prior Radiation Receiving SBRT: on
Feasibility, Safety, and Toxicity. Abstract #3236. Presented at
ASTRO 2024 October 1, 2024.
- Lin YH, et al. Impact of Hyaluronic Acid (HA) Rectal Spacer
Quality Score (SQS) and Fischer-Valuck (FV) Spacer Symmetry Score
on Rectal Dosimetry and Acute and Late Gastrointestinal (GI)
Toxicity Outcomes – an Australian Experience. Abstract #3222.
Presented at ASTRO 2024 October 1, 2024.
- 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).
- American Cancer Society. Key Statistics for Prostate Cancer.
www.cancer.org. 2023. Accessed: Jan 26, 2023.
https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.
- 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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