|[November 28, 2012]
Velomedix Receives IDE Approval for Randomized Pilot Trial to Evaluate Rapid Therapeutic Hypothermia in the Management of Acute Myocardial Infarction Patients
MENLO PARK, Calif. --(Business Wire)--
Velomedix, Inc., a venture-backed medical device company advancing the
field of therapeutic hypothermia, announced it has received
Investigational Device Exemption (IDE) approval from the U.S. Food and
Drug Administration (FDA) to expand the design of its VELOCITY pilot
clinical trial. This North American trial will evaluate the use of rapid
therapeutic hypothermia in the treatment of patients suffering an acute
myocardial infarction (AMI or heart attack). Positive discussions with
the FDA resulted in approval to include a control arm for a randomized
comparison, thus doubling the number of patients, and to increase the
number of U.S. trial sites.
Mild therapeutic hypothermia has been shown to substantially improve
outcomes for acute events, such as heart attack and cardiac arrest*.
While several technologies are currently being used clinically for
hypothermia management, Velomedix's proprietary technology delivers
unparalleled cooling speed, as demonstrated in previous clinical trials*.
This form of rapid cooling may enhance clinical outcomes and enable
widespread clinical adoption of this promising therapy. "More rapid
cooling may be critical to reduce infarct size in patients with heart
attacks undergoing angioplasty," commented Gregg Stone, MD, Columbia
University Medical Center / New York-Presbyterian Hospital and
co-principal investigator of the VELOCITY trial.
The VELOCITY trial is a 60-patient randomized trial at up to nine U.S.
investigational sites to evaluate the Velomedix Automated Peitoneal
Lavage System in patients with ST segment elevation myocardial
infarction, presenting within six hours of symptom onset. The study will
investigate the safety and feasibility of augmenting today's standard of
care (primary PCI (News - Alert)) with mild therapeutic hypothermia delivered by the
Velomedix system. "We are very excited that collaboration with the FDA
resulted in a randomized trial which will likely provide much more
clinically useful information than a comparison to historical control,"
said Jeff Gold, President and CEO of Velomedix.
The study's primary endpoint is a composite of specific new-onset,
serious adverse events during the first thirty days following treatment.
Several secondary endpoints will also be collected, including infarct
size, myocardial salvage, and left ventricular ejection fraction. Thus,
while primarily a safety trial, it will also gather meaningful efficacy
Graham Nichol, MD, University of Washington - Harborview Center for
Pre-Hospital Emergency Care, will be working with Dr. Stone as the other
co-principal investigator for this study. The trial is set to begin
enrollment before the end of 2012. More information on this trial can be
found at www.clinicaltrials.gov,
About Velomedix, Inc.
Velomedix is a private medical device company in Menlo Park, CA (News - Alert) created
to realize the clinical potential of mild therapeutic hypothermia in
patients suffering from acute vascular insults. These include heart
attack, cardiac arrest, and ischemic stroke. Therapeutic hypothermia
(TH) has been shown to reduce the ischemic and reperfusion effects in
these costly and debilitating conditions.
Unlike other cooling approaches, Velomedix's unique technology can
rapidly reduce patient temperatures to therapeutic levels. In clinical
studies outside the U.S., the system has achieved therapeutic
temperatures in less than 15 minutes on average*. This rapid
cooling rate may therefore make TH an effective enhancement to the
time-sensitive treatments of these patients.
For additional information, please visit www.velomedix.com.
Note: The Velomedix Automated Peritoneal Lavage System Investigational
Device is limited by Federal (United States) Law to Investigational Use.
* References available upon request
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