Jun 18, 2002

EECP for CHF gets FDA clearance
This Article is in Courtesy
of theHeart.org

Westbury, NY - Vasomedical Inc, has been granted market clearance for a new indication of CHF for its Model TS-3 Enhanced External Counterpulsation (EECP®) system. In its press release, Vasomedical estimates that the average medical practice could see the percentage of patients likely to benefit from EECP shoot from 2% to 20%, a market the company estimates could reach $2 billion in sales and services over the next several years in the US.



EECP is currently indicated and marketed for the treatment of angina, for which it receives Medicare reimbursement. Vasomedical now intends to actively pursue reimbursement and clinical acceptance for CHF.

The company is currently sponsoring the Prospective Evaluation of EECP in Congestive Heart Failure (PEECH) trial, which will study improvement of exercise capacity and quality of life for heart failure patients treated with EECP. That trial was started in response to a June 2000 decision by the FDA requiring Vasomedical to obtain a premarket approval before being allowed to claim CHF as an indication. The FDA told the company that with a reassessment of the system's safety profile, that June decision was overturned.

   
     
  HSC MEDICAL CENTER
Lot 3.6, Level 3, PNB Darby Park, 10 Jalan Binjai,
50450 Kuala Lumpur, Malaysia. (Location Map)
TEL: +60-3-2712 0866      FAX: +60-3-2712 0766 info@hsc.com.my

 

  
     
 
   
The information is provided for education purpose only and is not intended to represent the medical advice of your doctor or healthcare provider. Please consult your healthcare provider for advice about specific medical condition or contact HSC Medical Center.
       
| Home | About us | Medical Services | Diagnostic Packages | Facilities |
| For Doctors | Disease Prevention Chart | Location | Appointment | Contact us |