Marks first passive hemostat for Baxter in the
U.S. market, broadening portfolio offering to include a full range
of active and passive hemostatic products
Baxter International Inc. (NYSE:BAX), a global leader in
advancing surgical innovation, today announced the launch of
PERCLOT Absorbable Hemostatic Powder in the U.S.
PERCLOT is a passive, absorbable hemostatic powder that is
ready to use and designed for patients with intact coagulation to
address mild bleeding.1
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“PERCLOT is a strong complement to Baxter’s leading
hemostat portfolio,” said Steve Wallace, president, Advanced
Surgery at Baxter. “The launch of PERCLOT in the U.S. allows
us to provide surgeons with a full range of active and passive
hemostatic products for bleeding control, helping to optimize care
for their patients.”
To coincide with the launch of PERCLOT in the U.S.,
Baxter is working closely with key customers representing multiple
leading hospitals across the country to add PERCLOT to their
standard of care for low level bleeds. PERCLOT granules have
a molecular structure that rapidly absorbs water, forming a gelled
adhesive matrix that provides a mechanical barrier against further
bleeding and results in the accumulation of platelets, red blood
cells, and coagulation proteins (thrombin, fibrinogen, etc.).
PERCLOT further enhances clinicians’ ability to optimize
patient care by addressing a broader range of intraoperative
bleeding. Addressing intraoperative bleeding is important in
reducing blood transfusions and major complications for patients,
as well as lowering the total cost of care.2,3 A blood management
strategy that includes effective hemostasis is essential in today’s
environment where there is a shortage of blood donations.
Baxter has successfully continued to expand the global
commercial presence of PERCLOT since acquiring the product
in July 2021. To date, PERCLOT has sales in more than 35
countries worldwide.
For more information on PERCLOT, visit
https://advancedsurgery.baxter.com/perclot.
About PERCLOT
PERCLOT is a passive, absorbable hemostatic powder that
is ready to use and designed for patients with intact coagulation
to address mild bleeding.1 PERCLOT is composed of absorbable
polysaccharide granules. These granules are derived from purified
plant starch, biocompatible, non-pyrogenic, and do not contain any
human or animal components. PERCLOT granules have a
molecular structure that rapidly absorbs water, forming a gelled
adhesive matrix that provides a mechanical barrier against further
bleeding and results in the accumulation of platelets, red blood
cells, and coagulation proteins (thrombin, fibrinogen, etc.).4 It
is used as an adjunctive hemostatic device to control bleeding
during open and laparoscopic surgical procedures, including
gynecologic, general, cardiovascular, and urology.
About Baxter
Every day, millions of patients, caregivers and healthcare
providers rely on Baxter’s leading portfolio of diagnostic,
critical care, kidney care, nutrition, hospital and surgical
products used across patient homes, hospitals, physician offices
and other sites of care. For more than 90 years, we’ve been
operating at the critical intersection where innovations that save
and sustain lives meet the healthcare providers who make it happen.
With products, digital health solutions and therapies available in
more than 100 countries, Baxter’s employees worldwide are now
building upon the company’s rich heritage of medical breakthroughs
to advance the next generation of transformative healthcare
innovations. To learn more, visit www.baxter.com and follow us on
Twitter, LinkedIn and Facebook.
INDICATIONS
- PERCLOT Absorbable Hemostatic Powder is indicated in
surgical procedures (except neurological and ophthalmic) as an
adjunctive hemostatic device to assist when control of suture line
bleeding or capillary, venous, and arteriolar bleeding by pressure,
ligature, and other conventional procedures are ineffective or
impractical.
IMPORTANT RISK INFORMATION
- Do not inject or place PERCLOT into blood vessels such
as artery or vein as potential for embolization and death may
exist.
- Do not use PERCLOT for treatment of severe or extreme
bleeding.
- Do not inject into bladder or ureteral lumen.
- Single use only. Do not re-use. Do not re-sterilize. Re-use or
reprocessing of a single use device may lead to contamination and
compromised device function or structural integrity.
- Safety and efficacy of PERCLOT have not been clinically
evaluated in children (less than 21 years old) and pregnant or
lactating women.
- PERCLOT should be used with caution in the presence of
infection or in contaminated areas of the body. If signs of
infection or abscess develop where PERCLOT has been applied,
re-operation may be necessary in order to allow drainage.
- Safety and efficacy of PERCLOT in neurological and
ophthalmic procedures have not been established.
- Safety and efficacy of PERCLOT have not been clinically
evaluated for use in controlling post-partum bleeding or
menorrhagia.
- Once hemostasis is achieved, excess PERCLOT should be
removed from the site of application by irrigation and aspiration
particularly when used in the pericardial cavity and around
foramina of bone, areas of bony confine, the spinal cord, and/or
the optic nerve and chiasm. PERCLOT achieves its maximum
swelling within 10 minutes when exposed to blood or other fluids.
Dry, white PERCLOT should be removed. The possibility of the
product interfering with normal function and/or causing compression
of surrounding tissues due to swelling is reduced by removal of
excess dry material.
- The effect of this product on patients with known sensitivity
to starch or starch-derived materials has not been studied.
- The efficacy of PERCLOT in achieving hemostasis in
cortical bone and spinal bleeding has not been studied in
randomized clinical trials.
- Blood vessels, suture line gaps, and large needle holes with a
diameter of ≥2mm must be ligated prior to PERCLOT
application.
- Do not apply more than 50g of PERCLOT in diabetic
patients as it has been calculated that amounts in excess of 50g
could affect the glucose load.
- As with other hemostatic agents, do not apply PERCLOT to
sites where there is negative peripheral venous pressure as
material may be drawn into the vascular system potentially
resulting in life-threatening thromboembolic events.
Rx Only. For safe and proper use please refer to full
device Instructions for Use for Contraindications, Warnings, and
Precautions.
Forward-Looking Statements
This release includes forward-looking statements concerning
potential benefits associated with PERCLOT. The statements
are based on assumptions about many important factors, including
the following, which could cause actual results to differ
materially from those in the forward-looking statements: demand for
and market acceptance for new and existing products; product
development risks; inability to create additional production
capacity in a timely manner or the occurrence of other
manufacturing or supply difficulties (including as a result of
natural disasters, public health crises and epidemics/pandemics,
regulatory actions or otherwise); satisfaction of regulatory and
other requirements; actions of regulatory bodies and other
governmental authorities; product quality, manufacturing or supply,
or patient safety issues; changes in law and regulations; and other
risks identified in Baxter's most recent filing on Form 10-K and
Form 10-Q and other SEC filings, all of which are available on
Baxter's website. Baxter does not undertake to update its
forward-looking statements.
PERCLOT is a registered trademark of CryoLife, Inc.
Baxter is a registered trademark of Baxter International Inc.
1Assessment of the hemostatic efficacy of PERCLOT, Surgicel
Powder, and Arista in a Porcine Liver Abrasion Model. December
2021. Baxter Date on File. REF-36820.
2 Stokes et al.: Impact of bleeding-related complications and/or
blood product transfusions on hospital costs in inpatient surgical
patients. BMC Health Services Research 2011 11:135.
3 David A. Iannitti, Chong Kim, Diane Ito & Josh Epstein
(2021) Impact of an active hemostatic product treatment approach on
bleeding related complications and hospital costs among inpatient
surgeries in the United States, Journal of Medical Economics,
21:1,514-523, DOI: 10.1080/13696998.2021.
4 PERCLOT IFU
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version on businesswire.com: https://www.businesswire.com/news/home/20230724490511/en/
Media Peggy Dekker-Kuhnen, (224) 948-5353
media@baxter.com
Investor Clare Trachtman, (224) 948-3020
Baxter (NYSE:BAX)
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