Todd,
Here is the article from GDT in reference to a study they are starting on the Contak CD. It is not apparent why this study was started. I would venture to guess that the FDA told GDT that this data would be needed for approval. Not sure if this puts GDT ahead or behind MDT. But many implants of the Contak CD occurred before this new clinical started. If anyone has any info please share it with us.
Thanks,
Mike
Guidant to study device for treating heart failure
INDIANAPOLIS, Feb 7 (Reuters) - Guidant Corp. (NYSE: GDT), one of the largest medical device companies, said on
Monday that it is starting a new U.S. study on treatment for congestive heart failure, a cardiovascular disorder affecting millions
around the world.
The study, called COMPANION, follows Food and Drug Administration approval. Guidant is one of several medical device
makers targeting the heart failure population.
Heart failure is characterized by a gradual loss of pumping efficiency, leading to a number of problems including trouble
breathing, fluid retention and sometimes inability to live a normal life or carry out daily routines.
Guidant said heart failure affects well over 5 million people in the United States and an estimated 6.5 million in Europe. Nearly
1 million new cases are diagnosed annually, making it the most rapidly growing cardiovascular disorder.
"COMPANION is designed to help answer important questions associated with the use of implantable devices as new heart
failure therapy," said Jay Graf, president of Guidant's Cardiac Rhythm Management Group. "Patients will be randomized to
receive drug therapy alone or drug therapy in combination with implantable devices that resynchronize heart rhythms."
The study will collect and evaluate clinical data on more than 2000 patients in up to 80 centers across the U.S. to help
determine the best medical therapy for heart failure patients.
Dr. Arthur Feldman, President of the Heart Failure Society of America and professor at the University of Pittsburgh and Dr.
Michael Bristow, professor at the University of Colorado, are running the study.
It will evaluate several areas including ability to exercise, quality of life, length and frequency of hospitalization and survival rates.
Products to be evaluated include Guidant's CONTAK CD and TR pulse generators and the EASYTRAK lead, a patented
transvenous lead system implanted in the coronary vessels to coordinate stimulation of the left side of the heart with the right
side.
"Our early experience in Europe indicates that the CONTAK/EASYTRAK system can provide clinical benefit in the treatment
of patients who suffer from chronic heart failure," Graf said. Guidant's heart failure treatment systems have been sold in Europe
since last November. |
