Medical Device Daily Associate

In the wake of its recent physician communications, Guidant (Indianapolis) reported late last week that the FDA has classified the June 17 and June 24 communications (Medical Device Daily, June 21 and June 27, 2005) regarding certain models of its implantable cardioverter defibrillators (ICDs), with three of those 11 devices deemed Class I, the highest-priority status given by the agency.

The company said the FDA has designated as Class I recalls the previously disclosed physician communications concerning its Ventak Prizm 2 DR (manufactured on or before April 16, 2002) and its Contak Renewal 1 and 2 devices (manufactured on or before Aug. 26, 2004).

A Class I recall is one in which there is a reasonable probability that, if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or even death.

The FDA designated eight devices as Class II recalls. These devices were: the Ventak Prizm AVT; Vitality AVT; Renewal AVT; Renewal 3 and 4; Renewal 3 and 4 AVT; and Renewal RF devices

A Class II recall is one in which the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.

The company said these recall classifications do not affect its current recommendation to physicians and patients. Guidant recommends that physicians continue with normal follow-up patient visits at three-month intervals.

Neither Guidant nor the FDA is making a recommendation as to whether individual patients should have their devices removed. Rather, both believe that decision is best made by consultation between patients and their physicians, based on the specific case history of each patient. In certain cases, the risks associated with the surgery to explant the device will outweigh the extremely small risk of device malfunction.

“These are very complex clinical decisions that need to be made based on the device and the condition of the patient,” said Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, during a conference call about the ICD classifications. “We believe it is vitally important for the specific decision . . . to remain in the hands of the doctor and the patient.”

The company said it believes the FDA’s classification will “assist in its efforts to ensure that doctors and patients receive the necessary information to determine patient care.”

“The health and safety of patients is paramount,” said Guidant President and CEO Ron Dollens in a statement.

The company said that the FDA has acknowledged its efforts in communicating important safety information. It also recently disclosed its intention to establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices (MDD, June, 24, 2005).

Guidant said it plans to cooperate with and enlist the support of other interested parties, including the FDA, patient advocates, and physician societies.

Dollens said at the time of the panel announcement that the company “fulfills current regulatory reporting requirements” but acknowledged that “questions remain as to how companies can most effectively engage in a dialogue with physicians and patients. We believe that establishing this panel is an appropriate step in finding answers to these questions.”

The company still faces a slew of potential litigation in the wake of the recalls. The most damaging claims came from The New York Times, which reported in May that the company continued to sell an older version of one of the Class I recall devices, the Ventak Prizm 2 DR model defibrillator, even after developing an improved model of the device that was not prone to short-circuiting.

At least two patients with defibrillators made by the company have died, and Guidant said its devices had failed at least 45 times.