Sealant Shown to Inhibit Adhesions in Cardiac Procedures
PALO ALTO, CA -- September 20, 2001 -- Cohesion Technologies
Inc., a leader in developing and commercializing BioSurgical
products including surgical hemostats, sealants, adhesion
prevention barriers and adhesives, today announced
that CoSeal® surgical sealant was shown to significantly
reduce the formation, tenacity and surface area of
adhesions during cardiac surgery in preclinical models.
The results of this study were published in Heart Surgery
Forum by lead author Marc Hendrikx, M.D., Ph.D., Department
of Cardiothoracic and Vascular Surgery, Jesse Hospital,
in Hasselt, Belgium, in an article entitled "Evaluation
of a Novel Synthetic Sealant for Inhibition of Cardiac
Adhesions and Clinical Experience in Cardiac Surgery
In the study, CoSeal was compared with an approved
fibrin glue and with a surgical control. Eighty-eight
percent of CoSeal treated sites had no adhesions or
had adhesions of low tenacity. In comparison, zero
percent of the fibrin glue treated sites and 13 percent
of surgical control sites had either no adhesions or
adhesions of low tenacity. In addition, CoSeal significantly
reduced the percentage of treatment area with adhesions
as compared with the fibrin glue and the surgical control.
Commenting on the study, Dr. Hendrikx said, "We
were amazed by the adhesion prevention properties exhibited
by CoSeal in the study. The results were very impressive.
In addition, we observed that CoSeal also sealed vascular
grafts very effectively. Based on our work, CoSeal
seems to have multiple important applications during
cardiac surgery, addressing problems for which we currently
have few therapeutic options."
Pericardial adhesions subject patients requiring re-operation
to potential injuries to the heart, great vessels,
and cardiac grafts during the re-sternotomy. These
adhesions can severely complicate re-operations by
making re-entry hazardous, impeding orientation and
visibility, increasing the loss of blood, and prolonging
the operating time.
"CoSeal has demonstrated significant potential
in preclinical testing as an effective adhesion prevention
barrier," stated Frank DeLustro, Ph.D., president
and chief operating officer of Cohesion. "CoSeal's
synthetic composition, quick and easy preparation and
ability to adhere to tissue where it is applied and
remain in place during the critical wound-healing period,
could offer significant competitive advantages over
the limited and cumbersome alternatives available today."
CoSeal is currently marketed as a surgical sealant
in certain countries of Europe and in Australia. CoSeal
is a completely synthetic, self-polymerizing liquid
biomaterial that resorbs in less than 30 days. CoSeal,
which can be prepared in less than two minutes, is
easy to apply and adheres effectively to tissue to
seal around synthetic surgical materials such as Dacron
and PTFE. These product attributes are expected to
provide significant competitive advantages in the crowded
and hectic operating room setting.
SOURCE: Cohesion Technologies, Inc.
new studies on surgical mesh implants
By Anna Yukhananov
WASHINGTON | Thu Jan 5, 2012 12:15pm EST
(Reuters) - U.S. health regulators ordered new safety
studies for surgical mesh implants that are used to
hold pelvic organs in place, citing a spike in the
number of complications seen for female patients, including
erosion and infection.
The Food and Drug Administration also said it may reclassify
the devices in a higher-risk category that would require
manufacturers, such as Boston Scientific and a unit
of Johnson & Johnson, to conduct clinical trials
in people before receiving approval for sale.
The companies could not be immediately reached for
The devices, made of synthetic or biological material,
are commonly implanted in women to repair weakened
or damaged tissue and provide support in cases of pelvic
organ prolapse (POP). They are also used to help those
with a severe overactive bladder known as stress urinary
The FDA said it received more than 1,500 reports of
complications related to the repairs with mesh from
2008 to 2010, including cases in which the mesh eroded
into the vagina or caused bleeding and infection. The
rate of problems was five times the rate reported from
2005 to 2007.
The FDA sent letters this week to 35 manufacturers
of transvaginal surgical mesh, requesting three-year
studies of several hundred women each to study side
effects, as well as the women's overall quality of
In July, the agency warned that complications with
the mesh were "not rare" and that transvaginal
organ repair using mesh may put patients at greater
risk than other surgeries and treatments.
The FDA also said it was concerned about scientific
studies that show a lack of clinical benefit from surgical
mesh, compared to non-mesh repair.
About 75,000 women received mesh repairs for pelvic
organ prolapse in 2010 and about 200,000 women received
transvaginal repairs for stress urinary incontinence.
The agency is asking for more studies from companies
that sell the mesh for POP surgery. In the case of
mesh used to correct an overactive bladder, the FDA
is seeking further study of use of a so-called "mini-sling," when
strips of material are used around the bladder neck
and the urethra.
During their lifetime, 30 percent to 50 percent of
women may experience POP, with two percent developing
symptoms. The condition happens when tissue that holds
the pelvic organs in place becomes weak or stretched
and bulges into the vagina.
Surgery to support prolapsing organs can be done through
the abdomen or the vagina, either with stitches or
also with surgical mesh for reinforcement.
Surgical mesh has been used since the 1950s to repair
abdominal hernias, but doctors only started using the
mesh for POP and stress urinary incontinence in the
1990s, a procedure that has grown in popularity.
Companies that wanted to make the mesh specifically
for POP or urinary incontinence could submit their
application under a 510(k) accelerated review application
that did not require them to do clinical trials in
people, as long as they could show their implants were
similar to devices already on the market.
But during a panel meeting in September, outside advisers
to the FDA recommended that the agency reclassify the
devices for POP to require companies to submit additional
studies. The FDA said it is considering their advice.
Jeffrey Grand, a lawyer at Bernstein Liebhard in New
York, is representing women who are suing companies
that make the transvaginal mesh, with a case going
to trial later this year.
These things were basically put on the market without
any significant safety testing," Grand said. "I'm
hoping that all of this brings about some regulatory
Signs Agreement to Acquire Confluent Surgical
TYCO INTERNATIONAL SIGNS AGREEMENT TO ACQUIRE CONFLUENT
PEMBROKE, Bermuda – July 18, 2006 – Tyco
International Ltd. (NYSE: TYC, BSX: TYC) today announced
that U.S. Surgical, a subsidiary of Tyco’s Healthcare
segment, entered into a definitive agreement to acquire
Confluent Surgical, Inc., a leading developer and supplier
of polymer-based technology used in sprayable surgical
sealants and anti-adhesion products. The transaction
is priced at $245 million. The Boards of Tyco International
and Confluent Surgical have approved the transaction,
which is expected to close by the end of August. Tyco
expects to incur a charge in its fiscal fourth quarter
to write off in-process research and development.
Confluent Surgical, located in Waltham, Mass., markets
a neurosurgical sealant that was the first product
to receive Food & Drug Administration (FDA) approval
for use in cranial dural repair. This sealant, along
with several other products in the company’s
pipeline, is intended to improve patient outcomes by
reducing leaks or adhesions across various surgical
specialties. Over the next six years, the biosurgery
market—which is estimated at $900 million—is
expected to double in size. This acquisition helps
position Tyco Healthcare and U.S. Surgical to compete
effectively in that growing market.
Angiotech Gets Positive
Results in Study of Adhibit Spray Gel to Prevent
Wednesday September 28, 11:06 am ET
Angiotech Gets Positive Results in Study of Adhibit Spray Gel to Prevent Adhesions
NEW YORK (AP) -- Angiotech Pharmaceuticals Inc. said
Wednesday it received positive results from a clinical
study conducted to evaluate how safe and effective
its Adhibit Adhesion Prevention Gel is in reducing
scarring after uterine surgery.
Adhibit is a spray gel applied during surgery that binds directly to the tissue
and creates a temporary barrier, preventing contact and adhesions from forming
between tissue surfaces.
The company said the number of patients who suffered
from adhesions in the control group was double that
of the group receiving Adhibit -- 65 percent versus
33.3 percent. Safety data also indicated fewer adverse
events occurring with the Adhibit group than the control
The study was conducted at six sites in Germany, Canada
and Curacao. Patients who were scheduled to undergo
myomectomy surgery were randomized to either receive
Adhibit or be part of a control group. Patients then
returned 8 to 10 weeks later for a second-look procedure
and were evaluated for both extent and tenacity of
Uterine fibroids are benign tumors of muscle and connective
tissue that develop within, or are attached to, the
uterus. Fibroids are the most common pelvic tumor and
they may be present in as much as 70 percent of women,
for which surgery is a common treatment.
"One of the major challenges to date has been
to deliver an effective adhesion barrier through a
laparoscope, a technique that requires only a very
small scar as compared to the traditional and more
disfiguring technique of open surgery," said Rui
L. Avelar, senior vice president of medical affairs
for Angiotech. "Adhibit is a sprayable and versatile
adhesion barrier that can serve as a useful tool in
women's health-care and gynecological surgery."
Adhesions occur when normally separate tissues scar
together following surgery or tissue damage. Angiotech
said the incidence of adhesions is remarkably high,
particularly among patients with a history of multiple
surgeries and women with previous gynecologic surgeries.
Adhesions can be life threatening and can make follow-up
surgeries hazardous, and are also a leading cause of
female infertility and bowel obstruction.
Currently approved in Europe to prevent or reduce
post-surgical adhesions in pediatric patients undergoing
cardiac surgery, Adhibit is a synthetic, self-polymerizing
liquid hydrogel that is safely metabolized by the body
in less than 30 days.
Adhibit is sold and marketed by Baxter Healthcare
Corp., who also has an option to license Adhibit in
the U.S., but it is currently not approved for sale
in the United States.
Prevents Adhesions After Surgery in Mice
Feb 4th 2005: The recent finding that Celebrex may
help to reduce adhesions after surgery is a significant
finding for several reasons. Although the study reported
by Dr. Mark Puder and his colleagues at Children's
Hospital in Boston was performed in mice there are
several reasons for hope.
Principally, for the first time we have data that
shows that an approved drug is active orally against
adhesions. This provides important leads for future
research. There is a long way to go before this drug
should be used routinely in humans - there are a number
of safety concerns not only related to surgery itself
but also related to the ongoing controversy over the
use of COX2 inhibitors, of which Celebrex is a type.
This landmark study was published in the online version of the
prestigious journal "Annals of Surgery" . Dr. David Wiseman, founder
of the International Adhesions Society, had been invited along with two surgeons,
to review the manuscript as part of the peer review process and was able to
make some significant contributions regarding the presentation and analysis
of the data obtained in the study. Somewhat unusually Dr. Wiseman was acknowledged
in the paper, as "a reviewer."
"I sent the paper back about two or three times for revision because I wanted
to make sure that there was nothing ambiguous about this landmark paper. I'm
glad I was able to do my part to heighten the awareness about ARD and to offer
hope to all of its victims."
Press Release Source: Genzyme Corporation
Seprafilm® Efficacy Data Presented at Surgical
Meeting Shown to Reduce Incidences of Adhesive Small
Bowel Obstruction Following Colorectal Surgery
Tuesday May 11, 10:34 am ET
CAMBRIDGE, Mass., May 11 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq:
GENZ - News) today announced clinical data were reported that show Seprafilm® Adhesion
Barrier to be effective in reducing the incidence of adhesive small bowel
obstruction following colorectal surgery. The data were presented at the
annual meeting of the American Society of Colon and Rectal Surgeons in Dallas
and come from a five-year study involving nearly 1,800 patients.
Seprafilm is a temporary, physical adhesion barrier for abdominal and pelvic
adhesion prevention. Patients in this randomized, controlled, multi- center,
international trial underwent one of several colorectal procedures, with the
majority undergoing colon resection for inflammatory bowel disease. It is one
of the largest clinical studies of its kind.
In the treatment group, Seprafilm was placed throughout
the abdomen and pelvis with the intention to reduce
the incidence of adhesive small bowel obstruction.
The control group did not receive any anti-adhesion
barrier. The incidence of bowel obstruction of any
cause between the treatment and control groups did
not differ. Such results were not unexpected because
an obstruction can be caused by several factors, including
bowel stenosis and strictures, anastomotic complications,
and cancer -- conditions which would be unaffected
by the placement of an adhesion barrier.
However, detailed analysis indicated that Seprafilm
reduced the relative risk of a first adhesive small
bowel obstruction by 47 percent (1.8% vs. 3.4%, treatment
vs. control, respectively, p<0.05) in colorectal
surgery patients where the outcome was verified by
direct visualization. The study showed this led to
fewer repeat operations for adhesive small bowel obstruction
in the treatment group. There was no difference in
the overall rate of adverse events between groups.
In earlier Seprafilm studies involving 342 patients,
Seprafilm was proven to prevent adhesion formation
following both abdominal and pelvic surgery. However,
it was previously unknown if a reduction in adhesion
formation would lead to a reduction in the occurrence
of adhesive small bowel obstruction. These results
suggest that Seprafilm successfully reduces the incidence
of these events in patients undergoing colorectal surgery,
leading to fewer repeat operations.
"These results are very encouraging and confirm
that Seprafilm is safe to use for preventing adhesions
in colorectal surgery patients," stated Lena Holmdahl,
M.D., Ph.D., senior medical director, Genzyme Corporation. "We
believe the data will demonstrate the link between
adhesion reduction and clinical benefit that had been
missing until now."
"These data confirm that prevention of adhesions
with Seprafilm results in improved clinical outcomes,
specifically a clinically significant reduction in
the incidence of adhesive small bowel obstruction," said
David E. Beck, M.D. of the Ochsner Clinic and a lead
investigator in the trial. "We are encouraged
by the results and are seeing increased use of Seprafilm
in our institution as a result of our experience during
Questions regarding these data should be directed
to Genzyme Medical Information at 1-800-745-4447.
Seprafilm Adhesion Barrier is indicated for the reduction
of post-surgical adhesions in patients undergoing abdominal
or pelvic laparotomy. Seprafilm currently is not labeled
for use in preventing small bowel obstruction in colorectal
Seprafilm is one of a series of hyaluronic acid-based
products developed by Genzyme. The company's leadership
in biomaterials is built on nearly two decades of pioneering
work in the application of hyaluronic acid (HA) to
medical and surgical uses. HA also is the basis of
Synvisc® (hylan G-F 20) and the Hylaform® (hylan
B gel) product lines. Genzyme is working to extend
these products through significant development efforts
and to explore areas where HA may have a medical advantage.
The most common adverse events in Seprafilm clinical
trials, which were not different from untreated controls,
include ileus, anastomotic leak, and abdominal abscess.
Seprafilm should not be wrapped around an anastomosis,
as such usage may result in increased anastomotic leak
related events. Seprafilm has not been studied prospectively
in pregnancies, in the presence of frank infections,
or in malignancies.
About Genzyme Corporation
Genzyme Corporation is a global biotechnology company
dedicated to making a major positive impact on the
lives of people with serious diseases. The company's
broad product portfolio is focused on rare genetic
disorders, renal disease, osteoarthritis and immune-mediated
diseases, and includes an industry-leading array of
diagnostic products and services, and sophisticated
biomaterials. Genzyme's commitment to innovation continues
today with research into novel approaches to cancer,
heart disease, and other areas of unmet medical need.
More than 6,300 Genzyme employees in offices around
the globe serve patients in over 80 countries.
This press release contains forward-looking statements,
including the statements regarding the future prospects
for Seprafilm and Genzyme's efforts to expand its portfolio
of HA-based products to other applications through
additional development work. These statements are subject
to risks and uncertainties that could cause actual
results to differ materially from those projected in
these forward-looking statements. These risks and uncertainties
include, among others, the uncertainties associated
with conducting future clinical trials; the regulatory
approval process for new products; competitive product
development; the requirement for substantial funding
to conduct additional research and development work
relating to HA-based products; market acceptance of
new products; the ability to obtain and maintain patent
or other proprietary intellectual property protection
and the actual impact of those patents and rights;
and the risks and uncertainties described in reports
filed by Genzyme with the Securities and Exchange Commission
under the Securities Exchange Act of 1934, as amended,
including without limitation the information under
the heading "Factors Affecting Future Operating
Results" in the Management's Discussion and Analysis
of Financial Condition and Results of Operations section
of the Genzyme Annual Report on Form 10-Q for the quarter
ending March 31, 2004. Genzyme cautions investors not
to place undue reliance on the forward-looking statements
contained in this press release. These statements speak
only as of the date of this press release, and Genzyme
undertakes no obligation to update or revise the statements.
Genzyme®, Seprafilm®, Hylaform® and Synvisc® are
registered trademarks of Genzyme Corporation. All rights
Genzyme's press releases and other company information
are available at www.genzyme.com and by calling Genzyme's
investor information line at 1-800- 905-4369 within
the United States or 1-703-797-1866 outside the United
Media Contact: Investor Contact:
Maria Foley Kristen Galfetti
(617) 768-6690 (617) 768-6563
Disorder or CAPPS – a way to think about the
problem from the patient’s perspective.
Dallas TX. June 11 2010. The International Adhesions
Society (IAS) is proud to post on its adhesions.org
web site the results of groundbreaking and innovative
research which will forever change the way the problem
of adhesions is viewed.
The paper was published after Dr. Wiseman was invited
to submit a manuscript for inclusion in a special volume
of “Seminars in Reproductive Medicine” on
the subject of adhesions. The paper is entitled: “Disorders
of Adhesions or Adhesion-Related Disorder: Monolithic
Entities or Part of Something Bigger—CAPPS? “ (click
here for .pdf)
Since forming the International Adhesions Society
(IAS) in 1996, it became increasingly obvious that
the problems of patients suffering from adhesions were
not just about adhesions. Accordingly, we were the
first to coin the term “Adhesion Related Disorder” (ARD)
to include the entire complex of pain, infertility,
obstruction, nutrition, psychological and social issues
that ARD sufferers and their families experience.
Based on formal patient surveys as well as thousands
of emails and phone calls from patients, it became
apparent to us that even the term ARD may be inadequate
to address the problem. In reality, the ARD patient
is part of a much larger group of patients who, in
varying degrees, combinations and sequences experience
a range of symptoms and conditions including endometriosis,
interstitial cystitis (IC), irritable bowel syndrome
(IBS), bowel obstruction and chronic abdominal and/or
Although ‘‘adhesions’’ may
start out as a single, stand-alone entity, an adhesions
patient may develop a number of related conditions
(ARD) which renders those patients practically indistinguishable
from patients with multiple symptoms originating from
other abdominal or pelvic conditions. (continued)
Click here for a pdf copy of
the entire press release.
here for a .pdf copy of the CAPPS article
INTERGEL Withdrawn from
Market by Company
GYNECARE Voluntarily Suspends Marketing and Sales
of Anti-Adhesion Product Pending Evaluation of Postmarketing
of Johnson & Johnson) have voluntarily withdrawn
the anti-adhesion product - INTERGEL - from the market
pending an investigation into the circumstances surrounding
some adverse events including post-operative pain and
inflammatory reaction. There were also two deaths where
the product had been used after the accidental puncture
of the bowel. The relationship between the product
and these events is not certain, but the company are
WHAT TO DO IF YOU THINK YOU HAVE
HAD SIMILAR REACTIONS
The IAS has been contacted by a number
of patients who have asked us what to do if they believe
they have had a reaction to Intergel. Gynecare (a division
of Johnson & Johnson - the marketers of the product)
have kindly provided us with the following announcement:
"If you have had Intergel used during a surgical
procedure and have any questions about it or believe
you have had a reaction to it, you may contact Gynecare
directly by dialing 877-384-4266, option 1. This number
will connect you with a Registered Nurse who is trained
to respond to your call."
You may also contact your own doctor who will make
a report to the company, since this information will
be useful to them in determining the cause. (If you
do contact the company, let your doctor know this so
that s/he can inform the company). You can let
us know too if you wish.
For more information you can read the following press
releases (PDF), as well as a copy of the letter
sent to doctors (PDF) and the FDA
FzioMed's Oxiplex "Not
Approvable" According to FDA Panel BY DAVID KRESSEL,
JULY 16, 2008
On Tuesday, we attended the FDA's Orthopaedic & Rehabilitative
Devices Panel, Oxiplex/SP was voted "Not Approvable" by
a 5-2 vote, based largely on the sponsoring company's
inability to definitively demonstrate product effectiveness.
The two dissenters would have voted it "Approvable
Oxiplex is the lead product from FzioMed, a San Luis
Obispo, CA-based biomaterials company. Oxiplex is used
to prevent adhesions (peridural fibrosis), and is currently
distributed by J&J and Medtronic outside of the
US--it has been used in 100,000 surgeries to date.
There is currently no FDA-approved product to treat
spinal adhesions, though there are adhesion barriers
that are approved for general surgery and ob-gyn indications.
Oxiplex's indication would have been as a surgical
adjuvant during posterior lumbar decompression surgery
to improve patient outcomes by reducing post-operative
pain. The pivotal study's primary efficacy endpoint
was improvement in leg pain, as measured by the Lumbar
Surgery Outcomes Questionnaire (LSOQ). Of note, the
pilot study mentioned "reduction of adhesions" as
the indication, but this was removed for the pivotal
FzioMed's presentation focused on a complicated "multivariate
longitudinal” statistical analysis of the change
in leg pain from baseline to six months by GEE (Generalized
Estimating Equations)" which included ten covariates
and five treatment-by-covariate two-way interactions.
Their analysis showed that, in patients with more severe
back pain before surgery, there was a statistically
significant reduction in leg pain in the Oxiplex group.
The FDA's presentation focused on a series of simpler
analyses, none of which demonstrated statistically
significant reduction in pain scores. FDA's dataset
was also different from FzioMed's because FDA included
patients with results "out of window" for
6 month follow up (e.g. a patient who didn't visit
their surgeon at 6 months after surgery, but 12 months
The panel sided with FDA and believed FzioMed's statistical
method to be exploratory or post-hoc data mining. As
one surgeon-panelist said, "I see complex data
manipulation that I don't understand, and that worries
me." Even the biostatisticians on the panel were
skeptical of the validity of the analysis. The panel
was able to unanimously concluded that Oxiplex:
-Addressed a significant clinical need
-Might be effective
-Did not prove effectiveness in its trial results
Disagreement surfaced over whether the product should
be approved. Two panelists believed that the prospect
of a potentially effective, positively harmless, product
to treat an important problem with no other solution
Although many comments and questions from the panelists
and FDA could have been judged as statistical nitpicking,
the most interesting issue to arise was the fact that
nobody, not even the company, had any clue as to how
or why Oxiplex worked. FzioMed had a couple of unexplored
hypotheses, but nothing else. Although concerning on
its own, this also seriously undermined FzioMed's position
regarding subgroup analysis, because if there is no
understanding of the mechanism of action, there's no
reason to trust post hoc analysis suggesting the product
is more effective in a subgroup.
In the highly likely event FDA follows the panel's
recommendation, it appears FzioMed will have to decide
if it is interested in conducting a new clinical trial
to prove efficacy in the subgroup of patients with
worse baseline pain.