This decision is a historic step toward making the artificial heart available to most Americans
TUCSON, Ariz. (PRWEB) February 4, 2008
"Our proposal relaxes a long-standing non-coverage policy, gives access to our beneficiaries and promotes evidence development through FDA approved studies of this advanced technology," said CMS Acting Administrator Kerry Weems. "This device may be able to help patients that otherwise have no treatment options available to them."
"This decision is a historic step toward making the artificial heart available to most Americans," explained Rodger Ford, president and CEO of SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart. "Many smaller insurers use CMS reimbursement decisions as their benchmark for coverage."
The CardioWest artificial heart is currently covered by about half of insurers, including Aetna and BlueCross BlueShield. With final CMS approval, most insurers are likely to cover the CardioWest artificial heart.
On Aug. 1, 2007, CMS posted a notice to its web site announcing the review of this non-coverage policy, after SynCardia submitted a formal request for coverage of the CardioWest artificial heart when used in accordance with its FDA-approved labeling as a bridge to human heart transplant.
The CardioWest artificial heart received FDA approval on Oct. 15, 2004. It is the world's only FDA, CE and Health Canada approved temporary total artificial heart. It has been implanted in more than 700 patients, accounting for more than 120 patient years of life on the device.
See 28-year-old Vanessa Cirillo work out and box without a human heart.
Originally designed as a permanent replacement heart, the CardioWest artificial heart is currently approved as a bridge to transplant for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival depends on receiving a matching donor heart, or a CardioWest artificial heart as a bridge to transplant.
In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine 2004; 351: 859-867), 79 percent of patients receiving the TAH-t survived to transplant. This is the highest bridge to transplant rate for any heart device in the world.