February 7, 2008 Competition Doesn’t Wait for New Device By STEPHANIE SAUL
Dr. Robert Jarvik’s newest device, the Jarvik 2000, operates on a so-called continuous-flow basis — a design intended to have a lower failure rate than implantable heart-assist devices currently approved, which pulsate and are larger.
Dr. Jarvik’s product faces competition. Thoratec, which already markets a pulsating implantable device, is ahead of Jarvik Heart in gaining approval for an improved continuous-flow pump. A Federal Drug Administration advisory panel voted in December that Thoratec’s continuous-flow Heartmate II should be approved for use on patients who are awaiting heart transplants.
So far, though, the Jarvik 2000 holds the distinction of keeping a patient alive the longest. One British man lived for more than seven years after receiving the Jarvik 2000.
Medicare and some insurance companies already pay for the Jarvik 2000 in some cases, said Dr. O. H. Frazier, a surgeon who has implanted about 70 of the devices under an F.D.A.-approved experimental program; they cost about $70,000.
Dr. Eric A. Rose, a professor of surgery at Columbia, says such devices are as promising a development as kidney dialysis machines were in the mid-20th century.
Another cardiothoracic surgeon, Dr. John A. Elefteriades of Yale, who has used the device in about a half dozen patients, said Dr. Jarvik’s device would fill a niche. Rather than being used on the sickest patients near death, he said, it is meant primarily as an alternative to medical management for heart failure patients who are still ambulatory.
Meantime, the Jarvik 7, Dr. Jarvik’s original heart device, has been reincarnated.
The CardioWest, a heart modeled after the controversial Jarvik 7 of the 1980s, has been used in 700 patients as a bridge to transplantation. Dr. Jarvik no longer has a stake in the device, which is marketed by SynCardia Systems of Tucson.
Medicare said last week that it had made a preliminary decision to cover the CardioWest’s costs of $106,000, as well as use of a competing device.
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