MENLO PARK, Calif.--(BUSINESS WIRE)--
Velomedix, Inc., a clinical stage 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 evaluate the use of rapid therapeutic hypothermia for the treatment of patients suffering an acute myocardial infarction (AMI or heart attack). The conditional approval allows the company to initiate a clinical trial at select sites in the United States.
Therapeutic hypothermia has been shown to significantly improve outcomes for several acute events such as cardiac arrest, heart attack, and acute ischemic stroke. It has also been used with great success for spinal cord injury. While there are several technologies currently being marketed for hypothermia management, Velomedix’s proprietary technology delivers unparalleled cooling speed and procedural efficiency that is expected to result in enhanced clinical outcomes and enable more widespread clinical adoption of this promising therapy. “While current technologies can reach a therapeutic target temperature of 33C in 1-2 hours, the Velomedix system has shown the ability to achieve 33C in less than 15 minutes,” commented Jeff Gold, President and CEO of Velomedix. “For AMI patients requiring an intervention to open a blocked artery, the ability to deliver rapid cooling is crucial to optimizing the protective benefits of therapeutic hypothermia while still complying with mandated hospital ‘time-to-treatment’ standards,” added Griff Tully, MD, Velomedix’s Vice-President & Chief Medical Officer.
The recently approved IDE study will build upon limited, yet significant, data developed over the last 8 years for the use of therapeutic hypothermia for heart attack victims. Though the early randomized studies clearly pointed to the potential benefits of therapeutic hypothermia in this patient population, the effectiveness of the therapy was limited by the slow cooling times of the technologies employed and, as such, failed to meet the primary clinical endpoints. More recent studies have shown that rapid cooling, as enabled by Velomedix’s proprietary system, can result in clinical results that rival the best data extracted from earlier studies. Study patients who were rapidly and effectively treated with therapeutic hypothermia showed up to a 50% reduction in the amount of heart muscle lost during a major heart attack. This reduction is expected to correlate with improved survival rates and enhanced quality of life post-infarct.
It is anticipated the Velomedix IDE study will begin enrolling patients in the second half of 2012.
About Velomedix, Inc.
Velomedix is a venture capital backed clinical stage company located in Menlo Park, CA. Founded in 2007, the company has completed an initial human trial in the European Union (EU) that showed improved survival rates and neurological outcomes for patients suffering a cardiac arrest. In both the EU and the United States, awareness of the benefits of therapeutic hypothermia is growing and, in 2010, the American Heart Association (AHA) elevated the recommendation for therapeutic hypothermia for out-of-hospital cardiac arrest to a Class I. Yet clinical adoption of the therapy continues to be burdened by the insufficiencies of current approaches. Velomedix feels its rapid cooling approach has the potential to expand the clinical application and practical adoption of therapeutic hypothermia for the management of cardiac arrest patients as well as those suffering from a heart attack, stroke, traumatic brain injury, or spinal cord injury.
For additional information, please visit http://www.velomedix.com
Read more here:
Velomedix Receives IDE Approval to Evaluate the Use of Rapid Therapeutic Hypothermia in the Management of AMI Patients
- Hungarian Spinal Cord Injury Patient - Stem Cell Treatment Experience - May 7th, 2011 [May 7th, 2011]
- Stem cell treatment for Spinal Cord Injury (SCI)-Osama - May 8th, 2011 [May 8th, 2011]
- Spinal Cord Injury Patient after Stem Cell Treatment - Juan Carlos Murillo - May 10th, 2011 [May 10th, 2011]
- Spinal Cord Injury patient 10 years after injury after Stem Cell Treatment - May 10th, 2011 [May 10th, 2011]
- Rap Toward a Cure for Spinal Cord Injury - May 11th, 2011 [May 11th, 2011]
- Christopher "Kit" Bond - Spinal Cord Injury Stem Cell Patient - May 20th, 2011 [May 20th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (2) - May 21st, 2011 [May 21st, 2011]
- Spinal Cord Injury-After Treatment, Pt was completely paralyzed (2) - May 22nd, 2011 [May 22nd, 2011]
- Spinal Cord Injury-After Treatment, Pt was completely paralyzed (1) - May 23rd, 2011 [May 23rd, 2011]
- Dogs recover following new treatment for spinal cord injury - June 2nd, 2011 [June 2nd, 2011]
- Spinal Cord Injury Rehabiliation Success Story - June 3rd, 2011 [June 3rd, 2011]
- Stem Cells for Spinal Cord Injury: Community Outreach San Diego 2011 - Trish Stressman - June 7th, 2011 [June 7th, 2011]
- Stroke Client Gains Strength and Mobility in North Palm Beach Florida - June 9th, 2011 [June 9th, 2011]
- Spinal Cord Injury Chicago Rehabilitation Lokomat - June 10th, 2011 [June 10th, 2011]
- Spinal Cord Injury Treatment With Stem Cells - June 11th, 2011 [June 11th, 2011]
- Spinal Cord Injury Patient after Stem Cell Treatment - Wesley Hixen - June 12th, 2011 [June 12th, 2011]
- Stem Cell Therapy for Spinal Cord Injury - Injured Airline Pilot Flies Again - June 13th, 2011 [June 13th, 2011]
- David Chen: How would stem-cell therapies work in the treatment of spinal cord injuries? - June 17th, 2011 [June 17th, 2011]
- William Rader MD - Paralyzed Spinal Cord Injury Patient Walks Again - June 29th, 2011 [June 29th, 2011]
- The Spinal Cord Injury Treatment Team - July 4th, 2011 [July 4th, 2011]
- Introduction to the Bioness H200 Hand Rehabilitation System - July 14th, 2011 [July 14th, 2011]
- Organ repair using own stem cells -- brain, heart - Future Health keynote speaker - July 15th, 2011 [July 15th, 2011]
- 2011 Shriners Ride for Kids, Salt Lake City Utah. - July 17th, 2011 [July 17th, 2011]
- Degenerative Disc Disease: C5-C6 c6-C7 Treatment - July 18th, 2011 [July 18th, 2011]
- Rehabilitation Institute of Michigan's 60 Anniversary TV Commercial - July 18th, 2011 [July 18th, 2011]
- California Spinal Cord Injury Attorney: Obtaining damages for lifetime care. - July 19th, 2011 [July 19th, 2011]
- Physical and Mental Adjustments After a Spinal Cord Injury - July 19th, 2011 [July 19th, 2011]
- Comprehensive Inpatient Rehabilitation - July 28th, 2011 [July 28th, 2011]
- SCI Treatment Center at the Claremont Club - July 30th, 2011 [July 30th, 2011]
- Spinal Cord Inury Patient at XCell-Center- M. Hasan - August 5th, 2011 [August 5th, 2011]
- Spinal Cord Inury Patient at XCell-Center- K. Potts - August 6th, 2011 [August 6th, 2011]
- Magee Rehabilitation Hospital Foundation and Toyota 100 Cars for Good - August 13th, 2011 [August 13th, 2011]
- SCI_Celine_French_ifting_her_arms.wmv - September 1st, 2011 [September 1st, 2011]
- New Treatment May Help Paralyzed Patients Move Again By Dr.Zaghloul ahmed - September 1st, 2011 [September 1st, 2011]
- Claire Marsh - Spinal Cord Injury Part One - September 6th, 2011 [September 6th, 2011]
- Coping with spinal cord and traumatic brain injuries - September 10th, 2011 [September 10th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (3) - September 15th, 2011 [September 15th, 2011]
- Stem Cell Treatment - Spinal Cord Injury (1) - September 20th, 2011 [September 20th, 2011]
- Stem cell treatment by Adiva Health Care India after Spinal Cord Injury - September 22nd, 2011 [September 22nd, 2011]
- Spinal Cord Injury Documentary: You Will Never Walk Again, Part 1 - September 24th, 2011 [September 24th, 2011]
- Claire Marsh Returns - Spinal Cord Injury Patient - September 25th, 2011 [September 25th, 2011]
- Spinal Cord Injury: Raising awareness about research and treatment for spinal cord injury - September 26th, 2011 [September 26th, 2011]
- Walking after Spinal Cord injury and Stem Cells - September 27th, 2011 [September 27th, 2011]
- New Treatments for Spinal Cord Injuries - October 10th, 2011 [October 10th, 2011]
- Claire Marsh - Spinal Cord Injury Part Two - Video - October 18th, 2011 [October 18th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video - November 2nd, 2011 [November 2nd, 2011]
- Stem Cells - Treatment for Spinal Cord Injury - Video - November 2nd, 2011 [November 2nd, 2011]
- (Film Trailer) - The Spinal Cord Journey: Stem Cell Therapy Stories of Recovery - Video - November 27th, 2011 [November 27th, 2011]
- Stem Cell Treatment for T-6 Spinal Cord Injury - Video - December 7th, 2011 [December 7th, 2011]
- What is Project Walk Atlanta - Video - December 13th, 2011 [December 13th, 2011]
- Stem Cells Treatment for Spinal Cord Injuries, Successfully Results, Stem Therapy - Video - December 28th, 2011 [December 28th, 2011]
- Stem Cell Therapy for Spinal Cord Injury, India Mumbai - Video - January 6th, 2012 [January 6th, 2012]
- "April Crave", "Project Walk Spinal Cord Injury Recovery" - Video - January 10th, 2012 [January 10th, 2012]
- "Lori Hammond", "Project Walk Spinal Cord Injury Recovery" - Video - January 23rd, 2012 [January 23rd, 2012]
- "Chad C.""spinal cord Injury treatment" "spinal cord injury" "spinal cord injury recovery" - Video - January 23rd, 2012 [January 23rd, 2012]
- "Hugo Rodovalho", "Client Spotlight Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Cecilia V.", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Roy R.", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Angela", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Joey's Story", "Project Walk Spinal Cord Injury Recovery" - Video - January 27th, 2012 [January 27th, 2012]
- "Spinal Cord Injury", "A Story Of One" - Video - January 27th, 2012 [January 27th, 2012]
- Spinal Cord Injuries - The Healing Center Project! - Video - January 28th, 2012 [January 28th, 2012]
- "Crystal H.", "Project Walk Spinal Cord Injury Recovery" - Video - February 3rd, 2012 [February 3rd, 2012]
- "Dave D.", "Project Walk Spinal Cord Injury Recovery" - Video - February 5th, 2012 [February 5th, 2012]
- "Brook", "Project Walk Spinal Cord Injury Recovery" - Video - February 5th, 2012 [February 5th, 2012]
- "Ashley Vargas", "Project Walk Spinal Cord Injury Recovery" - Video - February 6th, 2012 [February 6th, 2012]
- "Nathan Bayer", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Annette Ross", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Joe Guintu", "Project Walk Spinal Cord Injury Recovery" - Video - February 8th, 2012 [February 8th, 2012]
- "Trevor Comeau,"Project Walk Spinal Cord Injury Recovery" - Video - February 9th, 2012 [February 9th, 2012]
- "Kyle Eade, "Project Walk Spinal Cord Injury Recovery" - Video - February 11th, 2012 [February 11th, 2012]
- Neuralstem Announces Closing of $5.2-Million Registered Direct Offering - February 14th, 2012 [February 14th, 2012]
- Chamber May Open Window for Treating Spine - February 15th, 2012 [February 15th, 2012]
- InVivo Therapeutics’ CEO Frank Reynolds Scheduled to Appear on Fox News First and San Antonio Living - February 17th, 2012 [February 17th, 2012]
- High doses of 'load' slows loss of bone in spinal cord injury - February 17th, 2012 [February 17th, 2012]
- InVivo Therapeutics Announces Pricing of Public Offering of Common Stock - February 17th, 2012 [February 17th, 2012]
- High Doses of Load Slows Bone Loss in Spinal Cord Injury - February 21st, 2012 [February 21st, 2012]
- InVivo Therapeutics Announces Full Exercise of Over-Allotment Option - February 22nd, 2012 [February 22nd, 2012]
- InVivo Therapeutics Announces Net $18.1M In Offering - February 22nd, 2012 [February 22nd, 2012]
- InVivo Therapeutics Prices 8.2M Shares Offering - February 22nd, 2012 [February 22nd, 2012]