The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Wednesday and Thursday, June 2 and 3, 2004 in Gaithersburg, MD.
(Topic 1) On June 2, 2004, the Panel made a recommendation to the Food and Drug Administration (FDA) on the approvability of the DePuy Spine, Inc. Charité Artifical Disc premarket approval application (PMA) P040006. The Charité Artificial Disc is intended for spinal arthroplasty in patients with single-level lumbar degenerative disc disease from L4-S1.
The sponsor and FDA summarized the safety and effectiveness data in the PMA. Two Panel members, a clinician and a statistician, then gave their perspectives on PMA data. After deliberations on the information in the submission, the Panel considered FDA’s questions.
The Panel then voted unanimously that FDA approve the PMA with conditions. The recommended conditions of approval are as follows:
- A postmarket study of all patients enrolled in the IDE study (including continued access patients) should be followed until the last-enrolled continued access subject reaches the two-year time point. The follow-up data from all these subjects should be provided to FDA.
- All patients who are treated with the Charité Artificial Disc should be provided with documentation describing the specific components of their implant, including associated lot numbers, as well as a telephone number to be used for the reporting of any adverse events.
- A post market in-vitro study to further assess wear debris. Wear debris testing should be conducted utilizing a combination of flexion/extension and lateral bending motions (without axial rotation) to determine if this combination would produce a different wear profile.
- FDA should consider required surgeon training.
- The FDA and the sponsor should discuss the following conditions of approval to come to a mutually agreeable course of action. This discussion will consider whether each items should be addressed pre- or post-market :
- Provide mobility testing data or complete references.
- Provide an adequate rationale for “normal biomechanics” including demonstration that facet joint strains/stresses are comparable to the control group patients.
- Provide an adequate rationale for not testing the biological response to submicron particles of ultra high molecular weight polyethylene.
- Clarify the neurological grading scale and how statistics were applied to this measure.
- Stratify results by indication group, particularly for patients with facet joint changes noted in preoperative assessments, for both the investigational and control groups.
- For those investigational patients with range of motion in the zero to five degrees range at the two-year time point, consider these subjects as failures, and reevaluate the study data.
- Consider if axial imaging can be done to compare facet degeneration at the index level at the 24-month time point and preoperatively.
- Provide radiographic evaluation of adjacent segement degeneration for the preoperative and 24-month time points, as well as through the follow-up period described in Condition #1.
(Topic 2) On June 3, 2004 in the morning, the Panel made a recommendation to FDA on the Orthopedic Surgical Manufacturers Association (OSMA) reclassification petition to reclassify the total mobile bearing knee (MBK) and unicompartmental MBK intended to replace the total knee or part of the knee joint, respectively, from class III into Class II.
OSMA members presented their MBK prostheses reclassification proposal, and an FDA reviewer presented the agency’s review regarding the proposed reclassification to the Panel. Two Panel members, a clinician, and a statistician then gave their perspectives on the information and data in the petition. After deliberations on the industry and FDA presentations and the information provided in the petition, the Panel considered FDA’s questions. The Panel then completed the reclassification questionnaire and summary data sheet.
The Panel then voted six to two to recommend that FDA reclassify the total MBKs into Class II. The Panel recommended five special controls to reasonably assure the safety and effectiveness of the device: 1) a special controls guidance document, 2) testing guidelines, 3) potential use of clinical data, 4) device specific training and labeling (to be negotiated with sponsors), and 5) patient identification cards (to include patient, surgeon, hospital, and implant information).
The Panel also voted five to three to recommend that FDA reclassify the unicompartmental MBK into Class II. The Panel recommended the same special controls as identified for the total MBK, with a stronger emphasis placed on the use of clinical data . In addition, the Panel also urged post market surveillance to track such adverse events as osteolysis, bearing dislocations, polyethylene failures, and revisions.
(Topic 3) On June 3, 2004 in the afternoon, the Panel made a recommendation to the (FDA) regarding OSMA’s guidance document submission entitled Clinical Trial Design for Hip Replacement Systems which was submitted to the Dockets Management Branch of FDA under 21 CFR 10.115(f)(3). The main focus of the submission was a proposed clinical study design for evaluating the safety and effectiveness of total hip joint replacement systems. The design includes a composite endpoint consisting of 3 objective performance criteria as a control for patient success with a benchmark for overall study success and a 4% delta for noninferiority. The panel was asked questions on the following topics which were discussed in detail during the meeting: the content of the proposed objective performance criteria and whether they are appropriate for the devices listed in the document, the proposed statistical plan, the duration of a study to provide assurance of safety and efficacy, suggestions about appropriate patient selection criteria, Outcome measures for surrogate endpoints, the need for post market studies and the hip systems that would be encompassed by such issues discussed. The panel’s responses to the six FDA questions on the guidance document constituted its recommendation on the draft guidance document.
Contact: Janet L. Scudiero, Executive Secretary, at 301-594-1184 ext. 176 or email@example.com.
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