FDA Classifies Prior Guidant Recalls; Guidant Reiterates its Previous Physician and Patient Recommendations.INDIANAPOLIS -- Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ) said today that FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has classified its June 17, 2005 and June 24, 2005 physician communications regarding certain devices. FDA has designated as "Class I" the previously announced physician communications concerning: --VENTAK PRIZM PRIZM Potential Rating Index for Zip Marketers (Claritas, Inc.) PRIZM Primal Zoo Machine (band) 2 DR (manufactured on or before April 16, 2002) --CONTAK RENEWAL 1 and 2 devices (manufactured on or before August 26, 2004) A "Class I" recall is the highest priority recall. This recall, which consisted of a letter to physicians and patients, was sent out on June 17. A Class I recall is one in which there is a reasonable probability that, if a particular device is malfunctioning mal·func·tion intr.v. mal·func·tioned, mal·func·tion·ing, mal·func·tions 1. To fail to function. 2. To function improperly. n. 1. Failure to function. 2. , the malfunctioning device will cause serious adverse health consequences or death. FDA has designated as "Class II" the previously announced physician communications concerning: --VENTAK PRIZM AVT AVT avian arginine vasotocin. See vasotocin. , VITALITY AVT, and RENEWAL AVT devices --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. These recall classifications do not affect Guidant's current recommendation to physicians and patients. Guidant recommends that physicians continue with normal follow-up patient visits at three-month intervals. Neither Guidant nor 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 explant /ex·plant/ 1. (eks-plant´) to take from the body and place in an artificial medium for growth. 2. (eks´plant) tissue taken from the body and grown in an artificial medium. ex·plant v. the device will outweigh the extremely small risk of device malfunction mal·func·tion v. 1. To fail to function. 2. To function improperly. n. 1. Failure to function. 2. Faulty or abnormal functioning. . Guidant believes 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," stated Ronald W. Dollens, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Guidant Corporation. "Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients." The actions taken by the company over the last several weeks reflect our commitment to provide more timely information to physicians and patients about our devices. Guidant has worked closely with FDA since the announcement of the physician communications, and has made FDA aware of all Guidant statements set forth in prior press releases, physician communications, and patient letters on this matter. Furthermore, FDA has acknowledged Guidant's efforts in communicating important safety information. Guidant will continue to work to meet and exceed the expectations of physicians, patients and FDA. Guidant recently announced 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. Guidant plans to cooperate with and enlist the support of other interested parties, including the Food and Drug Administration, patient advocates, and physician societies. For additional current information regarding expert and independent physician recommendations regarding response to device recalls, see the recent "Heart Rhythm Noun 1. heart rhythm - the rhythm of a beating heart cardiac rhythm regular recurrence, rhythm - recurring at regular intervals atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the Society Advisory Regarding Recalls for ICD's" at http://www.hrsonline.org/swAdvocacyFiles/advocacy103020093.asp. Additional information about the recalls is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://guidant.com/patient/communication/ This release includes forward-looking statements concerning the course of developments with respect to the affected products. These statements are based on assumptions about many important factors, including continuing developments with respect adverse event rates, regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. actions, and other factors identified on Exhibit 99 to the company's most recent 10-Q. Actual results may differ materially. The company does not undertake to update its forward-looking statements. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion