Key Findings from Unique Sex and Gender Symposium Help Advance the Development of Sex-Specific Medical Technology for Treating Vascular Diseases
Cook Medical Furthers Commitment to the Advancement of Sex-and
Gender-Based Medicine
BLOOMINGTON, Ind.--(Business Wire)--
The "Impact of Sex and Vascular Diseases and Implications for
Therapies" symposium uncovered a series of knowledge gaps related to
the sex differences in vascular disease, its symptoms, risk factors
and response to treatment. Conference recommendations could make a
significant impact on the health care industry ranging from clinical
trials to the development of medical technology and therapies.
Preliminary findings reveal that the basic biological make up of the
heart and blood vessels differs significantly between men and women
and may have a direct and dramatic impact on the prevention, diagnosis
and treatment of heart attacks, strokes and other forms of vascular
disease. Symposium faculty also report that reproductive hormones such
as estrogen heavily influence the progression and treatment of
vascular disease.
The Symposium's panel of experts identified seven key preliminary
findings that address the inherent differences between men and women
that could redefine sex-based medicine and research methodology in
vascular disease. The seven key findings include:
-- Sex Differences in Cardiovascular Disease: A knowledge gap
exists in the understanding of male and female patterns of
cardiovascular disease, symptoms and response to
treatment. The differences must be incorporated into all
aspects of future research including drug therapy and medical
device development.
-- Sex Differences in Clinical Research: The predominant pattern
in clinical trials is to combine males and females regardless
of the potential sex differences. To advance vascular
medicine, clinical research methodology must incorporate sex
differences when evaluating responses to treatments and test
performance. In addition, there is a general failure to note
women's hormonal status (i.e., premenopausal or
postmenopausal) when evaluating their responses to testing--a
situation that needs to be rectified.
-- Sex Differences Applied to Research Study Design: The role of
sex should not be limited to specifying the number of women
enrolled in a study. Methodology needs to include the
comparison of females to males; how study design identifies
sex differences; and how results are interpreted relative to
sex.
-- Sex Differences and Interdisciplinary Research: In general,
national conferences, scientific meetings and research
investigators tend to focus on a particular, isolated area of
research. By contrast, interdisciplinary gatherings can
identify collaborative areas of study and investigation.
-- Sex Differences in Regenerative Medicine: Sex differences in
regenerative medicine suggest that female stem cells, when
infused with male stem cells, support tissue regeneration,
whereas male stem cells alone are less successful. More
research is needed to understand what appears to make female
stem cells superior in this application.
-- Sex Differences and the Role of Reproductive Hormones: While
it is clear that hormones such as estrogen have an impact on
processes throughout the body, more study is needed to better
understand and identify how hormones impact heart rate, blood
pressure and other body processes, and particularly how they
affect vascular disease.
-- Sex Differences in Cellular Environment: Advances in biology
underscore the message that cellular environment must be
conducive for the growth and function of the
cell. Investigation designed to identify optimal surfaces to
attract the growth of healthy endovascular cells needs to be a
priority for further research.
The first-of-its-kind scientific symposium exploring sex-based
medicine's impact on the treatment of a wide array of vascular
diseases was conducted in February 2008 at Cedars-Sinai Medical Center
in Los Angeles. Co-chaired by Noel Bairey Merz,M.D.,and Saralyn
Mark,M.D, the conference brought together a renowned panel of
physicians and clinical research scientists to devise a plan of action
to address the significant discrepancies existing between men and
women in the prevention, diagnosis and treatment of vascular disease.
According to Dr. Bairey Merz, "The goal of the symposium was to
address the increasingly alarming discovery that women do not appear
to be receiving maximum benefit from our current strategies for
cardiovascular disease (CVD). A recent publication showed that while
overall CVD has declined by 52 percent in men and 49 percent in women,
there is an actual increase in CVD related deaths in younger,
middle-aged women, despite increased overall use of diagnostic
procedures and preventative medications."
"Vascular disease is the leading killer of both men and women and
yet little knowledge exists with regard to how sex differences impact
the development of these conditions," acknowledges Dr. Mark. "These
preliminary findings are a significant step toward eliminating the
knowledge gaps in vascular health and ideally will eventually change
how the medical and pharmaceutical industries identify and evaluate
the sex-based discrepancies in the diagnosis and treatment of vascular
disease."
"These preliminary findings will have a significant impact on how
the medical device industry designs and develops medical technology
and therapies for vascular medicine," said Christina Anne, vice
president of Cook Medical's vice president of Cook Medical's Women's
Health business unit. "A one-size-fits-all approach to medical
technology is no longer effective when treating male and female
patients. We are committed to working closely with symposium
participants and other scientific and medical community members to
provide minimally invasive medical devices that address gender-based
differences."
Sponsored by Cook Medical, symposium participants included Drs.
Leslee Shaw, Prediman K. Shah, Barbara Boyan, Doris Taylor, Noel
Bairey Merz, Alice Jacobs and Eduardo Marban. Representatives of the
Organization for the Study of Sex Differences (OSSD), the American
College of Cardiology (ACC), and the National Heart, Lung and Blood
Institute (NHLBI) also participated.
Faculty Member Titles and Affiliations:
-- Co-Chair, Primary Investigator: Noel Bairey Merz, M.D., FACC,
FAHA, Director, Women's Heart Center, Cedars-Sinai Heart
Institute
-- Co-Chair, Saralyn Mark, M.D., Associate Professor of Medicine
and OB-GYN at Yale and Georgetown Universities; Senior
Scientific Policy Advisor to Cook Medical
-- P.K. Shah, Director of Cardiology and Atherosclerosis
Research, Cedars-Sinai Heart Institute
-- Leslee J. Shaw, Ph.D., Professor of Medicine, Emory University
-- Barbara D. Boyan, Ph.D., Professor of Biomedical Engineering,
Georgia Tech and Emory Universities; Associate Dean for
Research, College of Engineering, Georgia Institute of
Technology
-- Alice Jacobs, M.D., Professor of Medicine, Director of Cardiac
Catheterization Laboratories and Interventional Radiology,
Boston University School of Medicine
-- Doris Taylor, M.D., Ph.D., Director of the Center for Vascular
Repair, University of Minnesota
-- Eduardo Marban, M.D., Ph.D., Director of the Heart Institute,
Cedars-Sinai Medical Center
About Cook Medical
Cook Medical was one of the first companies to help popularize
interventional medicine, pioneering many of the devices now commonly
used worldwide to perform minimally invasive medical procedures.
Today, the company integrates minimally invasive medical device
design, biopharma, gene and cell therapy, and biotech to enhance
patient safety and improve clinical outcomes in the fields of aortic
intervention; interventional cardiology; critical care medicine;
gastroenterology; radiology, peripheral vascular, bone access and
oncology; surgery and soft tissue repair; urology; and assisted
reproductive technology, gynecology and high-risk obstetrics. Founded
in 1963 and operated as a family-held private corporation, Cook is a
past winner of the prestigious Medical Device Manufacturer of the Year
Award from Medical Device & Diagnostic Industry magazine. For more
information, visit www.cookmedical.com
Cook Urology and Women's Health
Gail McDaniel, 812-339-2235 X7067
gail.mcdaniel@cookmedical.com
or
Racepoint Group, Inc.
Shannon Breen, 781-487-4607
sbreen@racepointgroup.com
Copyright Business Wire 2008
