Navigation Links
Angel Medical Systems Receives CE Mark Approval for the AngelMed Guardian, an Implantable Device Designed to Provide Early Warning of a Heart Attack
Date:9/22/2010

SHREWSBURY, N.J., Sept. 22 /PRNewswire/ -- Angel Medical Systems announced today that it has received CE (Conformite Europeenne) Mark approval for the commercial sale of The AngelMed Guardian System in Europe.  The Guardian System is an implantable early warning system designed to detect coronary occlusion from thrombotic events such as plaque ruptures and alert the patient, often before symptom onset.  The System is comprised of an internal implantable device about the size of a pacemaker with vibrational alerting.  The implant connects to the heart using a standard pacemaker lead.  External alerting is also provided by a pager-like external alerting device.

(Photo: http://photos.prnewswire.com/prnh/20100922/NY69751 )

(Photo: http://www.newscom.com/cgi-bin/prnh/20100922/NY69751 )

The CE Mark signals that a product is in compliance with all relevant EU legislation, making it eligible to be marketed and sold throughout the EU. The AngelMed Guardian is commercially available in Brazil and is currently being tested in the United States in the ALERTS Phase II Clinical Study under an investigational device exemption (IDE) from the FDA.

Dr. C. Michael Gibson of Harvard Medical School, who is leading the ALERTS study says, "Over the past two decades, it has routinely taken patients 2-3 hours to arrive at the hospital with a heart attack.  Our initial studies indicate that this device may reduce that time to approximately 20 minutes.  When time is muscle, every minute counts and our hope is that survival will be improved."

Dr. David Fischell, Chief Executive Officer of AngelMed adds, "Winning CE Mark approval in Europe offers a new avenue for our company to gain distribution, establish reimbursement networks, and to build relationships with thousands of cardiologists throughout the EU. The incidence of death from heart attacks is continuing to grow across Europe and the shortened time to treatment for heart attack that can result from early warning has the potential to reduce damage to the heart from heart attacks and save lives."

For more information on the AngelMed Guardian System or the ALERTS study, to go to http://www.angel-med.com.

Forward Looking Statements: Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company's products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.


'/>"/>
SOURCE Angel Medical Systems
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Artists for a New South Africa Will be Shaking The Blues at Gala Benefit November 15, With Performances by Erykah Badu, Nikka Costa, Keb Mo, Taj Mahal Trio, The Roots, and Guest Stars at The Wiltern in Los Angeles
2. Voices to Unite in Los Angeles for 6,000 Children Orphaned Daily
3. SpineMark Partners With Regional Spine Leaders to Launch Its First Multisite Spine Research Organizations in Los Angeles, Denver
4. University of California Los Angeles Selects Velos eResearch
5. Autism Spectrum Therapies Co-Founder and Chief Clinical Officer Dr. William Frea Appointed to Board of Directors of Los Angeles Chapter of Autism Speaks
6. Los Angeles Business Owner Pleads Guilty to Submitting Nearly $1 Million in False and Fraudulent Claims to Medicare
7. Thermal Angel Blood Warmer Recognizes CALSTAR 6 With Distinguished Emergency Responder Award
8. County of Los Angeles Fire Museum Presents Pioneers of Paramedicine(TM) Lifetime Achievement Award
9. American Red Cross of Greater Los Angeles Working With Philips Lifeline Medical Alert Service to Help Seniors Stay Independent
10. Consumers at Risk: One in Six Wood Pallets in Los Angeles Discovered With Potentially Deadly Pathogens
11. Award-Winning Thermal Angel Selected as Winner for Outstanding Military Product of the Year
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/27/2017)... 27, 2017  Zimmer Biomet Holdings, Inc. (NYSE and ... June 30, 2017.  The Company reported second quarter net ... the prior year period, and an increase of 2.1% ... points of contribution from the LDR Holding Corporation acquisition, ... quarter of 2016, or 0.3% on a constant currency ...
(Date:7/26/2017)... -- The Galien Foundation announced today the 2017 ... Award Nominees. Counted among the global health innovation industry,s ... and technology product achievement that improves the human condition. ... must be U.S. Food and Drug Administration (FDA) approved for ... to impact human health. Sales data are not considered by ...
(Date:7/21/2017)... and EDMONTON, Alberta , ... scientists and the University of Alberta in ... data in Nature,s partner journal, Schizophrenia 1 , ... predict instances of schizophrenia with 74% accuracy. This ... severity of specific symptoms in schizophrenia patients with ...
Breaking Medicine Technology:
(Date:7/28/2017)... ... 28, 2017 , ... At its first ginger symposium on July 18, 2017, ... industry. The funds will be used for land preparation, seed and organic farming for ... will support both new and existing small-hold farmers and will also help strengthen the ...
(Date:7/28/2017)... ... July 28, 2017 , ... Kevin Harrington, one of the original Sharks from hit reality series ... a new DRTV campaign with My Real Earth. , Most people put their healthcare above ... as important as what we put in our bodies. After all, the skin is the ...
(Date:7/28/2017)... , ... July 28, 2017 , ... The DuPage County ... hiring of associate Jennifer M. Cusack. Ms. Cusack joins the team ready ... Ms. Cusack graduated from Bradley University in Peoria, Illinois, with a BA in ...
(Date:7/28/2017)... ... 28, 2017 , ... Join Becker's Healthcare as they host their 3rd Annual ... IL. Great sessions on Epic, Cyber Security, Telehealth, Mobile Health, Revenue Cycle Optimization, Predictive ... George W. Bush, 43rd President of the United States ...
(Date:7/28/2017)... ... July 28, 2017 , ... Lundquist Insurance ... to business owners and families across east Texas, is embarking on a charity ... the greater Dallas area. , America’s Mighty Warriors offers a series of programs ...
Breaking Medicine News(10 mins):