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| May 5, 1997 | January 29-30, 1998 | November 17, 1998 | June 16, 1999 |
| January 12, 2000 | March 1-3, 2000 | May 8, 2000 |
(Complete transcript is available at http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3276t1.pdf.)
The General and Plastic Surgery Device Panel met on Monday May 5, 1997 at 9200 Corporate Blvd. in Rockville, Maryland. The purpose of the panel meeting was to review and vote on a Premarket Approval Application (PMA) from Genzyme Corporation on Sepracoat. Sepracoat is a 0.4% solution of hyaluronic acid in a phosphate buffered saline, intended to reduce post-operative formation of de novo adhesions resulting from incidental tissue damage in abdominal/pelvic surgery.
In the morning there was a one hour training session for new panel members.
The panel meeting began at 8:30 am with the introductions of the panel followed by updates by the Division of General and Restorative Devices on the Tissue Initiative and the PMA approval of Dermagraft-TC on March 18, 1997. The PMA had been reviewed by the panel at the last meeting on November 19, 1996.
The morning session included an hour presentation by the PMA Sponsor followed by questions from the panel. Then the presentation by the FDA with questions from the panel. The FDA questions on the PMA were then presented to the panel.
In the afternoon the primary panel reviewers gave their presentation of PMA issues to the Panel. The FDA questions were discussed with additional questions from the panel to the Sponsor and FDA. The vote was then taken. a motion was made for not approvable. The panel voted 6 to 0, unanimously, in favor of the motion. The panel then provided comment on ways the Sponsor could place the application in an approvable form. These included suggesting the Sponsor do a new study, evaluating other endpoints such as adhesion formation other than de novo, and recommending other second look surgical procedures for evaluating adhesion formation.
Contact: Gail Gantt, telephone 301-594 3090, E-mail ggg@cdrh.fda.gov
[A transcript of this meeting may be purchased from Miller Reporting Co., 507 C Street, NE, Washington DC 20002, telephone 202-546-6666, fax 202 -546-1502, or from FDA, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857, telephone 301-443-6310, fax 301-443-1726.]
(Complete transcript is available at http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3371t1.pdf and http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3371t2.pdf.)
The General and Plastic Surgery Devices Panel met on Thursday January 29, 1998 and Friday January 30, 1998 at the Gaithersburg Marriott Washingtonian Center in Gaithersburg, Maryland.
The purpose of the panel meeting was to review, make recommendations and vote on three Premarket Approval Applications (PMAs).
On Thursday morning a PMA on Dermagraft manufactured by Advanced Tissue Sciences was reviewed. Dermagraft is a dermal replacement consisting of neonatal dermal fibroblasts cultured in vitro onto a bioabsorbable mesh. The indication for use reviewed in the PMA was plantar diabetic foot ulcers. The panel voted 7 to 2 for approvable with conditions. The conditions were that the sponsor perform a prospective, concurrently controlled study to examine the effectiveness of the 2x3 inch narrow MTT range Dermagraft product in plantar diabetic foot ulcers and to develop a training program for health professionals on product use.
During Thursday afternoon a PMA on Graftskin manufactured by Organogenesis was reviewed. Graftskin is a three layer allogeneic skin substitute consisting of neonatal keratinocytes/bovine collagen/neonatal fibroblasts. The indication for use reviewed in the PMA was venous stasis ulcers. The panel voted 5 to 4 that the PMA was approvable.
The PMA on Dermabond manufactured by Closure Medical was reviewed on Friday. Dermabond is a sterile, liquid, cyanoacrylate, topical skin adhesive used for wound edge approximation. The panel voted 8 to 0 for approvable with conditions. The conditions were that the instructions for use include information on thorough wound cleansing and the use of local anesthesia prior to application of Dermabond, and that wound closure be limited to the superficial layer of skin with instructions for closure of the deeper layers of skin before the application of Dermabond.
(Contact: Gail Gantt, telephone 301-594-3090 ext. 135, E-mail: ggg@cdrh.fda.gov)
[A transcript of this meeting may be purchased by written request only from Freilicher and Associates, Suite203, 11923 Parklawn Drive, Rockville, MD 20852, telephone 301-881-8132 or fax 301-881-9364, or from FDA, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857, telephone 301-443-6310, fax 301-443-1726.]
GENERAL AND PLASTIC SURGERY DEVICES PANEL - November 17, 1998
Summary is not available
Transcript is available
11/17/98
GENERAL AND PLASTIC SURGERY DEVICES PANEL - June 16, 1999
The General and Plastic Surgery Devices Panel met on June 16, 1999 at the Gaithersburg Hilton (620 Perry Parkway, Gaithersburg, Maryland) to provide advice and recommendations to the Agency for a premarket application submission.
Before the Panel was asked to provide advice and recommendations, there were three
items of general business. First, Mr. Stephen Rhodes (Branch Chief, PRSB) gave the Panel
an update of panel related activities since the last meeting in November. In his update,
Mr. Rhodes indicated that the FDA is working on a final rule classifying four types of
wound dressings, a guidance document on surgical meshes has been completed, guidance
documents on breast implants and wound dressings are being updated, a new guidance
document for sutures is being prepared and FDA is planning to publish a final rule later
this year calling for PMAs for safety and efficacy data for saline-filled breast
prostheses. Next, Dr. Larry G Kessler (Director, OSB/CDRH) gave a brief presentation on
"Postmarket Evaluation at FDA’s Center for Devices and Radiological
Health." His presentation focused on the methods of device postmarket evaluation at
the Center. Finally, Mr. Jim Dillard presented an award to Dr. James Burns (the Panel
Industry Representative) "in recognition of distinguished service from the General
and Plastic Surgery Panel and Medical Devices Advisory Committee."
The Panel meeting was a discussion of the PMA for the Intuitive Surgical Endoscopic
Instrument Control System and Intuitive Surgical Endoscopic Instruments. The Intuitive
Surgical System had been cleared in July 1997 (K965001) for a limited set of instruments
(e.g., blunt dissectors, retractors, rigid endoscope and stabilizers) and was intended for
accurate control of these instruments during thoracoscopic and laparoscopic surgical
procedures. The focus of the discussion was on the addition of new instruments, to include
scissors, scalpels, forceps, needle holders, clip appliers and electrocautery instruments
so that the system could be used for the additional indications of grasping, cutting,
electrocautery and suturing. In January 1999, the sponsor submitted a premarket
notification [510(k)] for the added instruments and indications. The FDA decided that this
was not substantially equivalent because the system raised new questions of safety and
effectiveness as compared to the previously cleared system. The Panel was asked to provide
recommendations and advice for the Intuitive Surgical Endoscopic Instrument Control System
and Intuitive Surgical Endoscopic Instruments PMA.
The sponsor presented an overview of their Endoscopic Instrument Control System and
associated Endoscopic Instruments and then presented data from their prospective,
randomized, single masked, single center, four-investigator, conventional laparoscopic
tool controlled clinical trial. The study involved the enrollment of 245 patients
undergoing one of two surgical procedures: 120 patients were enrolled into the
laparoscopic cholecystectomy arm and 125 were enrolled into the laparoscopic Nissen
fundoplication arm. Approximately half the patients in each surgical group were treated
using conventional laparoscopic procedures and the other half were treated using the
subject device to perform the surgery.
For the laparoscopic cholecystectomy cohort, the primary effectiveness endpoint was
successful removal of the gall bladder without conversion to, for the investigational
device, to conventional laparoscopic technique or, for control, to open technique. The
secondary endpoints were equivalent procedure time, hospital stay and quality of life
score for both arms. The laparoscopic Nissen fundoplication cohort used the same efficacy
endpoint with the added criterion of an equivalent reduction in DeMeester score (the
measurement of gastroesophageal reflux) for patients in each arm.
While no procedures were converted to conventional techniques due to failure of the
Intuitive System, three investigational device randomized procedures were
intra-operatively converted prior to activation of the investigational device: two to
control, one to open technique. Conversions to control appeared to have been due to
surgeon inexperience. The panel ultimately felt that these conversions were not a
shortcoming of the subject device but a function of training. The sponsor also presented
data on three system faults with the investigational device where the device transitioned
into safe mode. These three cases prolonged the surgical procedure time by 12 to 20
minutes. These device failures required active engineering intervention and resulted in
system and system use modifications.
There was a brief closed session at the beginning of the afternoon session from 1:30 pm to
2:00 pm during which the sponsor discussed with the panel confidential commercial
information. This portion of the meeting was closed to the general public.
Following panel deliberations and discussion of FDA’s questions, the panel voted 9 to 1 to recommend approval of the device with 2 conditions of approval: 1) That the approval not include the clip appliers since they were not used in the procedures supporting the application and 2) that Intuitive Surgical Inc., propose to FDA a comprehensive training program for surgeons and the entire surgical team who are to operate the system.
David Krause, PhD
Executive Secretary
General and Plastic Surgery Devices Panel
Transcripts may be purchased from Miller Reporting Company, Inc., 507 C Street, N.E., Washington, DC 20002, 202-546-6666; 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).
GENERAL AND PLASTIC SURGERY DEVICES PANEL - January 12, 2000
No summary is available
The complete transcript is available.
GENERAL AND PLASTIC SURGERY DEVICES PANEL - March 1-3, 2000
The General and Plastic Surgery Devices Panel met on March 1-3, 2000 at the Gaithersburg Holiday Inn at Two Montgomery Village Avenue in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for 3 premarket approval applications and to give advice on labeling and patient informed consent materials for women contemplating the use of saline-filled breast implants.
The meeting began with Mr. Phil Phillips (Deputy Director, ODE) giving the panel an update on the current understanding of the Least Burdensome provisions of the FDA Modernization Act of 1997. This was followed by public testimony from 37 scheduled individual consumers, consumer groups, consumer information providers and professional societies. Following the public testimony, Dr. Celia Witten (Director, DGRD/ODE) brought the panel up to date in regards to the Regulation of Saline-Filled Breast Prostheses. During this presentation Dr. Witten highlighted the history of the regulation of saline-filled breast implants and the guidance documents that FDA has prepared for the manufacturers of these medical devices. She further pointed out that these guidance documents identify the types of chemistry, toxicology, and mechanical testing recommended by the agency and also the types of clinical data that should accompany a premarket approval application for saline-filled breast implants. The final presentation before panel consideration of the PMAs was by Dr. Wendie Berg of the University of Maryland who is a consultant to the Radiological Devices Panel. Dr. Berg discussed Considerations on Imaging Patients with Breast Implants. She focused on the goals of mammography and the difficulties associated with mammography of the breast for women with breast implants. The important fact was that a great deal of the breast tissue is obscured by the implant thus making cancer detection more difficult.
The last order of business on the first day of the panel meeting was for
discussion and recommendations on the PMA application for Mentor Corporation’s
Saline-Filled Breast Prostheses. The Breast Prostheses are silicone elastomer
shells, which are filled with sterile saline at the time of surgery. The focus
of the panel discussion was on the preclinical and clinical data submitted by
the sponsor. The Panel was asked to provide recommendations and advice to the
FDA on this application.
The sponsor presentation highlighted the results obtained from a number of clinical studies. The data presented was from the Surveillance Epidemiology and End Results (SEER) Program of the National Cancer Institute, the Large Simple Trial (LST), the Saline Prospective Study (SPS) and the Mentor Retrospective Study. The discussion focused on the prospective SPS study, which was implemented at many centers in the US. This was an open label, prospective study with 3-year follow-up data. Safety was determined by the assessment of complications and effectiveness was assessed by the determination of breast dimensions, patient satisfaction and Quality of Life measures. The study enrolled 1265 patients undergoing breast augmentation with the implantation of 2528 implants and 428 patients undergoing breast reconstruction with the placement of 589 implants. The 3-year follow up was completed by 76.3% of the augmentation patients and 75.5% of the reconstruction patients. The cumulative rate of a first occurrence of any complication was 43% for augmentation patients and 73% for reconstruction patients at 3 years as assessed by Kaplan-Meier statistical analyses. The panel voted 9 to 1 to recommend approvable with conditions. The conditions included a requirement that Mentor Corporation work with FDA to complete and update the mechanical testing, that Mentor continue to collect long-term follow-up data, that Mentor perform further statistical analyses of the data, and that all efforts be made to fully inform patients of all potential risks associated with the use of breast implants.
During the second day of the meeting the panel considered PMA applications from McGhan Medical and Poly Implant Prostheses (PIP). The McGhan Medical discussion included a review of their preclinical and clinical data. The panelists agreed that except for fatigue and fold-flaw testing, McGhan had successfully completed all of their preclinical testing. The major portion of the discussion focused on the clinical data supplied by McGhan Medical in regards to their open label, prospective study, which proposed 5-year follow-up and had completed 3-year follow-up for most patients and 4-year for many patients. This study assessed safety by determination of complications and assessed effectiveness by monitoring breast size, patient satisfaction and Quality of Life measures. The study had two arms, one for augmentation patients and one for reconstruction patients. The augmentation arm of the study enrolled 913 patients undergoing and included the placement of 1800 devices. The reconstruction arm of the study enrolled 256 patients and included 316 devices implanted. Both augmentation and reconstruction patients were generally satisfied with their surgeries. The four-year cumulative rate of a first occurrence of a complication was 60% for the augmentation patients and 84% for the reconstruction patients by Kaplan-Meier analyses. The panel voted unanimously to recommend approval with conditions for this PMA. Some of the conditions were that the sponsor continue long-term follow-up, to revise the risk characterization in reconstruction, and to include literature information.
The panel discussion of the PMA application for Pre-filled Saline Breast Implants from PIP focused on the difficulty of assessment of these devices based on incomplete data for both the preclinical and clinical aspects of their product. The discussion of the clinical study focused on a French Clinical Study and a U.S. Discretionary Postmarket Surveillance (DPS) study. The panel members felt that the French Clinical Study could not be used as a stand alone study and the data from US study was needed to gain a greater understanding of the safety and effectiveness of the PIP implants. There was little two year follow-up data available from the US DPS study. The panel voted unanimously to recommend that this PMA was not approvable. The panel members stated that the major factors in their recommendation were that the preclinical and clinical data were not complete.
The final day of the panel meeting focused on the type of information that should be available to women considering breast surgery for breast augmentation and/or breast reconstruction. This included information that was to be placed into the labeling intended for the patient, the labeling intended for the physician, and also the information that would go into the informed consent documentation. The panel members were asked to comment and provide specific suggestions on important information to include in these documents and the form that this information should take, to comment on whether a waiting period would be appropriate in order to provide the patient with adequate time to make an informed decision, to comment on postoperative symptoms that should cause patients to seek medical consultation, to discuss the types of information patients should be given regarding differences in surgical procedures and postoperative care and to discuss other elements that should be added to patient information. The general consensus of the panel was that patient labeling should include as much information as possible to address all possible risks and complications with information on expected outcomes. The information should also be focused on product specific data.
David Krause, Ph.D
Executive Secretary
General and Plastic Surgery Devices Panel
(301) 594-3090 ( x141)
Transcripts may be purchased from
Neal R. Gross & Company
1323 Rhode
Island Avenue, NW,
Washington, DC 20005,
phone: 202-234-4433; FAX: 202-387-7330
or
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)
GENERAL AND PLASTIC SURGERY DEVICES PANEL - May 8, 2000
The General and Plastic Surgery Devices Panel met on May 8, 2000 in Salons F&G of the Gaithersburg Marriott Washingtonian Center at 9751 Washingtonian Boulevard in Gaithersburg, Maryland, to provide advice and recommendations to the Agency for two premarket application submissions.
The Panel Meeting began at approximately 8:00 am with Mr. Stephen Rhodes updating the Panel Members on events related to the Panel that had occurred since the Panel last met in March of 2000. In his update, Mr. Rhodes indicated that the FDA is working to bring closure to the review of the Saline-filled Breast Prostheses premarket approval applications, which were the subjects of last March’s Panel Meeting.
The morning session of the Panel Meeting concerned a PMA for Focal, Inc.’s
FocalSeal-L Synthetic Absorbable Sealant. The FocalSeal-L Synthetic Absorbable
Sealant molecule is comprised of a water soluble poly(ethylene glycol) group
modified with acrylic ester endgroups, which are connected to each other by
lactic acid-trimethylene carbonate, biodegradable segments. The material is
applied to tissue in a non-polymerized form and chemically and photo-polymerized
on the lung tissue into an absorbable hydrogel polymer that is intended to seal
air leaks over suture or staple lines following lung surgery or trauma. The
Panel was asked to provide recommendations and advice for the FocalSeal-L
Synthetic Absorbable Sealant (P990028).
The sponsor presentation focused attention on a product overview and preclinical data summary and the clinical study design and results. Preclinical testing, in accordance with ISO 10993, demonstrated that the sealant was non-cytotoxic, non-sensitizing, a slight irritant, non-toxic, non-hemolytic and non-pyrogenic. Also, the sealant was non-mutagenic in the Ames Bacterial Mutation Test, the Chromosomal Aberration (CHO cells) Test and in the standard (4 hour) Mouse Lymphoma Assay. However, the result was weakly positive in the modified (24 hour) Mouse Lymphoma Assay. The clinical study was designed as an open label, prospective, randomized (2:1), multicenter study. The protocol compared standard tissue closure procedures to standard closure procedures plus the application of FocalSeal-L Sealant. Patients were stratified into high and low risk strata based on preoperative and intraoperative (air leak) risk factors. The study was performed at 4 research centers with the first two patients at each center considered pilot patients who were assigned to the treatment group. These patients were excluded from the efficacy analyses but included in the safety analyses. The primary efficacy endpoint was a between-group comparison of the percent of patients that were air leak-free from the time of skin closure through the time of hospital discharge. Secondary endpoints were the time to air leak cessation and the percent of patients that were air leak-free at the time of skin closure. The study also assessed the time to chest tube removal, the time to hospital discharge for each patient in each group and the incidence of air leak recurrence.
A total of 180 patients were enrolled into the clinical study (8 pilot patients, 117 patients randomized to FocalSeal-L and 55 patients randomized to Control). The percentage of patients that remained air leak-free before randomization were comparable between groups: 24% (30/125) FocalSeal-L; 29% (16/55) Control. Based on the total number of patients randomized, the percentage of patients that remained air leak free from skin closure through hospital discharge were 39% (108/117) for FocalSeal-L and 11% (6/55) for Control. The number of patients with air leak recurrence after skin closure was comparable between groups: 57% (62/108) FocalSeal-L; 63% (10/16) Control. Based on the number of patients who were air leak free at the time of skin closure, the percentage of patients that remained air leak free from skin closure through discharge were 43% (46/108) FocalSeal-L 37% (616) Control. The mean time to air leak cessation was 30.9 h for FocalSeal and 52.3 h for Control while the proportion of patients that were air leak-free at the time of skin closure was 92% in the FocalSeal-L group and 29% in the Control group. The mean time to chest tube removal was 4.5 days for FocalSeal-L patients and 5.2 days for Control patients, however, the median was 4.0 for both groups of patients. A similar pattern was noted for days to hospital discharge, which was 7.4 days for the FocalSeal-L patients and 10.1 days for the Control patients when looking at the means, but 6.0 days for both groups when looking at the median.
During the Panel deliberations, the Panel was asked to discuss the adequacy of the preclinical testing performed on FocalSeal-L and on the safety profile obtained during the preclinical testing. The Panel was also asked to comment on the fact that thoracic wound infections and empyema were 7.2% and 3.2%, respectively, in the FocalSeal-L group and only 3.6% and 0%, respectively, in the Control group and that cancer progression was 10.4% in FocalSeal-L patients and 7.3% in Control patients. Finally, the panel was asked to comment on the safety and effectiveness of the FocalSeal-L Synthetic Absorbable Sealant in light of the 21 CFR 860.7 definition of safety and effectiveness. Following Panel deliberations, the panel voted unanimously (8-0) to recommend approvable with conditions. The majority of the Panel Members indicated that they felt that the sponsor had shown clinical effectiveness and relative safety of the device in the target population. The conditions of approval included that the Package Insert should contain a maximum number of product applications per patient, information regarding the possible increased rate of infection and empyema with product usage, a warning that the product has not been tested with any types of additives (antibiotics, etc.) and that the sponsor should undertake a post-market study that captures the rates of tumor progression and infection.
The afternoon portion of the Panel Meeting dealt with the safety and effectiveness of Organogenesis Inc.’s Apligraf® product when used on diabetic foot ulcers. In their presentation, the sponsor pointed out that Apligraf® is presently indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than one month duration and which have not adequately responded to conventional ulcer therapy. The sponsor would like to extend this indication for use to include the treatment of full-thickness neuropathic diabetic foot ulcers of greater than 2 weeks duration that extend through the dermis but without tendon, muscle, capsule or bone exposure.
The sponsor presentation and panel discussion focused on the multicenter, prospective, randomized, controlled clinical trial that compared the use of standard therapy plus Apligraf® to the use of standard therapy alone. Standard care for this type of foot ulcer consists of extensive debridement of nonviable tissue, the application of saline-moistened dressings and the off-loading of weight from the foot to decrease pressure on the damaged areas of skin. In order to participate in the trial, patients needed to have Type 1 or Type 2 diabetes, be between the ages of 18 and 80 years and have full-thickness neuropathic ulcers of at least 2 weeks duration that were between 1 and 16 cm2 in size. In the standard care plus Apligraf® group, Apligraf® would be applied between 1 and 5 times in a four week period. The additional applications would be made at weekly intervals if there was less than 100% wound closure and the wound did not appear to be progressing to healing. Off-loading was achieved by placing the patient on crutches or a wheelchair for the first 6 weeks of the study and then by applying customized pressure-relieving footwear for study duration.
The study was performed at 24 investigational sites and randomized 277 patients of which 208 were treated, 112 in the Apligraf® group and 96 in the Control group. Patient demographics and baseline ulcer characteristics were comparable. The primary effectiveness endpoint was complete wound closure on or by week 12. Complete wound closure was defined using the Wound Healing Society definition of full epithelialization of the wound with the absence of drainage. The frequency of complete wound closure observed was 56% in the Apligraf® group and 38% in the Control group (p = 0.0082). The other primary effectiveness endpoint was the median time to complete wound closure, which was 65 days for the Apligraf® group and 90 days for the Control group (p = 0.0026). There were no significant differences in secondary endpoints; durability of response and ulcer recurrence.
During the panel deliberations the FDA asked the Panel to comment on the clinical use of Apligraf® on patients with Charcot’s foot disease and to discuss the impact of ulcer location on Apligraf® performance. Also, the Panel was asked to comment on the safety and effectiveness of Apligraf® in light of the 21 CFR 860.7 definition of safety and effectiveness. Following Panel deliberations, the panel voted unanimously (6-0) to recommend approvable with conditions for the device. The majority of the Panel Members indicated that they felt that the sponsor had shown clinical effectiveness and relative safety of the device in the target population. The conditions of approval included only some adjustments to the labeling. The panel recommended that the sponsor include in the label statements that the use of the device be limited to use after failure of standard therapy, that FDA should carefully examine how effectiveness is described in the label and that the labeling state that Apligraf® has not been compared to human skin autograft.
David Krause, PhD
Executive Secretary
General and Plastic Surgery Devices Panel
(301) 594-3090, x141
Transcripts may be purchased from Neal R. Gross & Company, 1323 Rhode Island Avenue, NW, Washington, DC 20005, 202-234-4433 (voice) or 202-387-7330 (facsimile); 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 (facsimile).
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