FDA Approvals: VeriChip, CardioWest Temporary Artificial Heart, Fuzeon, and More

Yael Waknine

October 21, 2004

Oct. 21, 2004 — The U.S. Food and Drug Administration (FDA) has approved an implantable computer chip that allows retrieval of personal medical history by authorized personnel in emergencies, an implantable artificial heart for use as a bridge to transplantation, enfuvirtide for use in combination treatment of HIV-1, an implant to replace arthritic trapezialmetacarpal thumb joints, and a terminally stabilized version of a skin regeneration system.

Chip Implant (VeriChip) Allows Emergency Retrieval of Personal Medical History

On Oct. 13, the FDA approved a computer chip (VeriChip, made by Applied Digital Solutions, Inc.) for implantation under the skin in a brief outpatient procedure. The 12 mm by 2.1 mm radiofrequency identification device contains a 16-digit patient verification number that is transmitted to a handheld radio scanner upon activation.

Using the number displayed on the scanner, physicians and other emergency and ambulance personnel are able to retrieve medical information regarding blood type, drug history, and other patient-approved critical data from a secure computer database via telephone or Internet.

The device has the potential for use in security, financial, and other non–FDA approved applications.

Device (CardioWest Temporary Total Artificial Heart) Improves Survival to Transplant

On Oct. 18, the FDA approved an implantable bridge-to-transplantation device (CardioWest Temporary Total Artificial Heart, made by SynCardia Systems, Inc.) for use in patients eligible for heart transplant who are at risk of imminent death from nonreversible biventricular failure.

The pneumatic, biventricular implant system is a full cardiac replacement that restores normal blood pressure and cardiac output to avoid end-stage organ failure and improve the patient's health at the time of transplantation.

The approval was based on the recommendations of an outside panel of experts, and an FDA review of clinical studies showing that 79% of 81 transplant-eligible patients with severe biventricular heart failure survived an average of 79 days to receive a donor heart.

Adverse events included infection (72%), bleeding (42%), neurologic events such as major and minor stroke (25%), and device malfunctions (18%).

The FDA is requiring the company to conduct a postapproval study to monitor its commercial use.

Traditional Approval Granted for Enfuvirtide (Fuzeon) for Treatment of HIV-1

On Oct. 15, the FDA granted traditional approval to the fusion inhibitor enfuvirtide (Fuzeon, made by Roche and Trimeris, Inc.), which is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The approval was based on the results of two international 48-week, randomized, open-label phase 3 clinical trials involving 1,000 patients with prior history of use and/or resistance to each of the three other classes of anti-HIV drugs. In these trials, enfuvirtide-based regimens significantly reduced HIV RNA levels in 46% of patients compared with 18% of patients receiving standard-of-care therapy.

Injection-site reactions occurred in most patients (98%). Trial data showed that enfuvirtide-based regimens decreased the incidence (per 100 patient-years) of diarrhea (38 vs 73), nausea (27 vs 50), and fatigue (24 vs 38) compared with other therapies.

Enfuvirtide was granted accelerated approval by the FDA in March 2003 based on 24-week data.

Implant (PyroHemiSphere) for Replacement of Arthritic TMC Thumb Joints

On Sept. 17, the FDA approved a hemi-arthroplasty implant (PyroHemiSphere, made by Ascension Orthopedics Inc.) to replace the base of the metacarpal bone in the trapezialmetacarpal (TMC) joint of thumbs debilitated by arthritis.

The implant is made of a strong, low-friction, biologically fixed and inert material (PyroCarbon) and does not require fixation with cement or other compounds. It is the first joint implant made of this material to be granted FDA approval.

The approval was based on the results of clinical studies showing that the implant was effective in relieving pain, improving or preserving motion, and reducing dislocated or subluxated TMC joints in patients suffering from osteoarthritis, rheumatoid arthritis, and arthritis due to trauma.

Terminally Stabilized Version of Dermal Regeneration Template (Integra-TS) Improves Use

On Oct. 11, the FDA approved a terminally stabilized (TS) version of a skin regeneration system for excised wounds (Integra Dermal Regeneration Template [IDRT]-TS, made by Integra Lifesciences).

The TS system has an inner fiber matrix layer that serves as a scaffold for regenerating dermal skin cells and a silicone outer layer to protect the wound from infection and control heat and moisture loss. The silicone layer is replaced by an epidermal skin graft after dermal regeneration.

Functionally equivalent to the earlier version, the TS system has modified packaging and storage requirements that facilitate its handling and use in the operating room. It does not require refrigeration, can be stored flat, has a shorter rinse time prior to application, and is available in a 2" by 2" size.

The TS system was granted approval for use in the European Union on Oct. 11.

Reviewed by Gary D. Vogin, MD


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