The General and Plastic Surgery Devices Panel (GPS Panel) met from 8:00 am to approximately 4:15 pm on July 24, 2003 in Salons A, B, & C at the Gaithersburg Hilton Hotel at 620 Perry Parkway in Gaithersburg, Maryland in order to provide advice and recommendations to the FDA regarding the reclassification, from Class III to Class II, of the absorbable hemostatic agent devices and regarding breast tumor coagulation necrosis clinical trials issues. The meeting consisted of a brief closed session and an open session. During the closed session, Mr. Stephen Rhodes (Branch Chief, DGNRD) gave the Panel Members a briefing on some of the devices for which they may be providing advice and recommendations over the next few years.
After a short recess, the open portion of the panel meeting began at 8:30 am with Mr. Rhodes updating the committee on events related to panel activities that had occurred since the panel last met on February 28, 2003. In his update Mr. Rhodes stated that FDA continues to work with Artes Medical toward the approval of their PMA for Artecol®; that on March 11 the agency approved a panel-track PMA supplement for Inamed’s CosmoDerm and CosmoPlast devices, injectable implants made from human collagen intended to treat soft tissue contour defects, such as wrinkles and acne scars; that on March 20, the agency published a proposed rule to classify silicone sheeting for scar management as Class I devices; and that on June 3 the agency published a Class II Special Controls Guidance Document for multiple surgical sutures.
The panel then proceeded to the discussion of the proposed reclassification of the absorbable hemostatic agent devices from Class III to Class II. Industry representatives from Johnson & Johnson Wound Management Worldwide, Ferrosan A/S, and Integra LifeSciences as well as FDA provided information attesting to the safe and effective use of these devices for over 50 years. Following the discussion, the panel voted unanimously to reclassify the absorbable hemostatic agent devices into Class II with the definition: “An absorbable hemostatic agent, surgical is an absorbable device intended to produce hemostasis by accelerating the clotting process of blood during surgical procedures. It is absorbable.” The panel also agreed unanimously that the “Indication for Use” statement containing similar language to the following was acceptable: “An absorbable hemostatic agent, surgical is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
In the afternoon, the Panel convened to discuss the clinical trial issues pertaining to the study of thermal coagulation necrosis devices (such as radiofrequency ablation, focused ultrasound, focused microwave, interstitial laser photocoagulation and cryoablation) for the treatment of breast cancer in lieu of local resection.
The Panel first discussed the level of evidence required from an “ablate and resect” feasibility study before a pivotal, “ablate and follow”, clinical trial be undertaken. The Panel’s recommendations regarding the confidence level of ablation targeting and completeness ranged between 95% to100%, and they recommended that these results be reproducible among centers and investigators. They recommended that in both the feasibility and pivotal trials, the term ablation be defined with respect to what constitutes ablation success and failure.
The panel then discussed a possible pivotal trial study design to examine the safety and effectiveness of thermal ablation devices for the treatment of breast cancer in lieu of local resection. Many panel members recommended using these technologies in patients with small (< 2 cm) breast cancers however some discussed the advantages of studying the use of these devices in patients with larger cancers. All of the panel members recommended a controlled study design – either concurrent or historical. As a concurrent control, many recommended standard of care treatments as the control however some felt that patients treated only with the device without radiation therapy could be an option. Their suggested endpoints to such a pivotal trial included local recurrence, cosmesis, and survival. The recommendations for duration of follow-up ranged from 5 to 10 years.
The panel discussed the effects of breast cancer thermal coagulation necrosis on local tissue radio/chemosensitivity. The panel agreed that the local tissue effects such as tissue hypoxia are not presently well understood. They recommended that this be addressed either by directly studying local tissue effects in the rodent model and/or by indirectly examining local control and survival rates in patients treated by breast cancer ablation and adjuvant treatments.
During the course of their discussions, the Panel expressed concerns regarding the ability of imaging modalities to adequately visualize tumor margins under certain circumstances. They felt that further study and development of imaging modalities should be undertaken.
Also during the course of their discussions, the Panel expressed concerns regarding the large sample size that would be required to conduct studies demonstrating thermal ablation device safety and effectiveness for breast cancer treatment in lieu of local resection. They recommended that assistance for conducting such trials be sought from federal agencies and/or professional societies.
Contact: David Krause, Ph.D., Executive Secretary,General and Plastic Surgery Devices Panel
(301) 594-3090, x141
Transcripts may be purchased from Neal R. Gross; 1323 Rhode Island Avenue, NW; Washington, DC 20005, 202-234-4433; or from the Food and Drug Administration, Freedom of Information Staff (FOI), 5600 Fishers Lane, HFI-35, Rockville, MD 20852, 301-827-6500 (voice) or 301-443-1726 (FAX).