The FDA recall of tissue products processed by CryoLife (Kennesaw, Georgia) last month did not include the company's heart valve products, an exemption that offered a ray of hope for the company that now faces an uphill battle to regain customer and shareholder confidence. The FDA ordered it to recall all of its cadaver tissues processed after Oct. 3, 2001, and to destroy any of those tissues processed since then. Following the recall, however, the FDA issued a specific order saying that the company's heart valves are exempt from the order because these devices "are essential for the correction of congenital cardiac lesions in neonate and pediatric patients and no satisfactory alternative device exists." However, the agency still noted "serious concerns" regarding the processing and handling of allograft heart valves by CryoLife because patients who receive the devices may be at increased risk of infection.

The FDA recall was based on concerns, it said, that the company could not guarantee that the materials specified were free of fungal and bacterial contaminants, specifically citing the death of a Minnesota man who received a soft tissue implant during knee surgery last November. The recall produced a sharp dive in CryoLife's share price and was just one more in a series of problems facing the company. A product liability suit connected with the death in Minnesota has been filed against the company and it faces a spate of shareholder suits. Additionally, after the FDA recall, the company acknowledged an SEC investigation.

In response to CryoLife's troubles, Vice President David Fronk said that he thought that the recall, and other actions facing the tissue engineering sector, would make both the company and the industry stronger. He said CryoLife had launched a series of discussions with the FDA, including an appeal of the recall order, and that it has instituted a variety of actions to ensure product safety.

Steven Anderson, president and CEO, said CryoLife would begin a major effort to gain FDA clearance for its Synegraft bovine allograft heart valves. These grafts have been implanted as arteriovenous (AV) access devices and for peripheral vascular reconstruction. Since February 2000, Anderson said approximately 813 SynerGraft valves have been implanted. Of these, 800 remain implanted.

Additionally, the company has implanted 648 processed SynerGraft patches for cardiac reconstruction. The company found upon examination of the explanted allograft heart valves that the valves were remodeling in vivo. Also, since January 2001, CryoLife reported implantation of about 394 vascular grafts processed with SynerGraft technology. About 381 of these grafts remain implanted. CryoLife received the CE mark for SynerGraft vascular grafts made from bovine ureters in August 2001.

As a result of what it called successful clinical results of the SynerGraft bovine vascular grafts for AV access, CryoLife has moved up the priority of these grafts and will apply for an investigational device exemption (IDE) in 4Q02. The company said it expects to gain IDE approval by 1Q03 and will enroll patients in a clinical trial at that time. Based on a trial timeline of two years and required administrative follow-up, it thinks it could receive premarket approval by late 2005 or early 2006.

"Based on market data available, we anticipate that the device could potentially address up to 75,000 to 80,000 of the 234,000 AV access procedures performed annually in the U.S., and with an anticipated charge for the grafts of $1,200," Anderson said. He noted that number is three times the $400 sales price of current AV access grafts. He added that because the device is made from a bovine ureter, it does not have the supply constraint of human vascular grafts.

In a related move, the company said it would withdraw its IDE for the CryoLife-O'Brien prosthetic heart valve. Anderson said this strategy will help focus the company on the SynerGraft Vascular IDE for AV access and could save the company about $2 million a quarter. CryoLife will continue to distribute the valve internationally.

Guidant go-ahead may expand ICD market

Millions of Americans with a history of heart attack and impaired heart function in late July got a new treatment to prevent death from cardiac arrest. The FDA approved an expanded indication for Guidant's (Indianapolis, Indiana) family of implantable cardioverter defibrillators (ICDs) to include cardiac patients who have had previous heart attacks with an increased risk of sudden cardiac death. The approval means a potential 3 million to 4 million people in the U.S. could be candidates for the device, according to statistics from the FDA. "If you've had a heart attack and you have suppressed heart function, you should discuss with your physician whether you're a candidate for one of these devices," said Helen Barold, MD, the FDA medical officer who made the approval announcement.

"This expanded FDA indication for Guidant implantable defibrillators provides us an excellent opportunity to serve a much broader group of people at known risk for sudden cardiac death," said Fred McCoy, president of the company's cardiac rhythm management division, in announcing the approval. Guidant has ICD models in single- and dual-chamber versions. There are currently 11 dual-chamber models and 15 single-chamber models on the market.

Patients who receive an ICD also must have an ejection fraction of 30% or less, with levels at or below 30% indicating impaired function and an increased risk of sudden cardiac death. Previously, to be approved for an ICD, a patient had to undergo invasive electrical testing using a catheter or have survived serious cardiac arrest. Guidant said it is the only manufacturer to have approved labeling for implantable defibrillators that includes the expanded patient group.

The FDA based its decision on the results of the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II, which demonstrated a 31% reduction in the risk of death in patients with an ICD compared to those in the medical therapy group. The eligibility criteria for MADIT II included the patient experiencing a myocardial infarction at least 30 days prior to implantation. Of the 1,200 patients enrolled in the MADIT II study, 742 received an ICD and the remaining 490 were treated with medical therapy alone. A small percentage of patients (3%) did have complications with the device, but there were no deaths associated with it. Patients with ICDs were more likely, however, to be hospitalized with congestive heart failure during the study. Guidant ICDs have been implanted in more than 65,000 patients.

AbioCor recipient dies after nine months

James Quinn, the fifth person implanted with an AbioCor artificial heart from Abiomed (Danvers, Massachusetts), died at Hahnemann University Hospital (Philadelphia, Pennsylvania) after suffering a stroke Aug. 23. Quinn was withdrawn from life support Aug. 26 after being unresponsive to efforts to improve his condition since suffering the stroke three days earlier. His death leaves one person, Tom Christerson, surviving in Abiomed's trial of the replacement heart (related item in Product Briefs, page 15).

Quinn had been supported by the AbioCor heart for more than nine months, having been implanted with the device last Nov. 5 by the cardiac transplant team at Drexel University College of Medicine and Hahnemann University Hospital, led by Louis Samuels, MD.

Robert Kung, MD, senior vice president and chief medical officer for Abiomed, said in a statement, "Everyone at Abiomed has the utmost respect for the courage, tenacity and will to live that James exemplified. We are thankful for the contribution he has made and the opportunity to know him." Samuels said, "James Quinn was a very special man. He was a courageous man. He became part of my family and I will truly miss him."

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