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FDA advisory committee recommends premarket approval of synthetic cartilage implant for first MTP joint
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The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the FDA recommended a synthetic cartilage implant should be given premarket approval for the treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint.
The panel voted 10 to 2 that the synthetic cartilage implant Cartiva (Cartiva Inc.) is safe, voted 9 to 3 that the implant is effective and voted 8 to 2 with 2 abstaining votes that the benefits of the implant outweigh its risks. The panel focused on results of the MOTION study, which showed patients who received the synthetic cartilage implant in the first metatarsophalangeal (MTP) joint experienced a high success rate while undergoing a shorter surgery, maintained motion in the MTP joint and avoided risks of nonunion and hardware fracture compared with patients who underwent fusion.
Safety, effectiveness
Although temporary voting member of the panel John D. Kelly IV, MD, of the University of Pennsylvania in Philadelphia, expressed a few concerns regarding the study design, he noted the synthetic cartilage implant has potential and should be given a chance.
“I have expressed my concerns, and some of them profound, over the study design and I am having a hard time letting go of all those people who had fusions which were not indicated, in my considered opinion,” Kelly, who is also an Orthopedics Today Editorial Board member, said. “However, I think this [device] has potential promise. I am a big fan of minimally invasive treatment, and this may serve as a useful adjunct in treatment of MTP arthritis.”
However, other members of the panel noted there was not enough proof that the device was effective and that the study left unanswered questions on clinical outcomes.
“I do not think we can say if it is effective or not, partly because we are comparing apples and oranges,” voting panel member Maureen A. Finnegan, MD, FRCS(C), of the University of Texas Southwestern Medical Center in Dallas, said. “It would have been nice to see a motion-retaining control group instead of a fixed-motion control group, and as well that pain was not one of [the sponsor’s] outlined objectives originally, but I think [the sponsors] do need to look into pain and see why those patients are having pain.”
Post-approval studies
If the FDA chooses to issue premarket approval for the synthetic cartilage joint, the panel advised that post-approval studies be performed for a period of 5 years to determine survival rate, as well as whether any other safety issues occur. The panel also noted there should be strict limitations on the indications for use, which would exclude patients with hallux valgus or an “unstable joint.”
“I think we need to give this device a chance, but I think it needs to be deployed in a limited sort of way with a careful registry follow-up with the patients at least, so that we can see about their longer-term outcome with a commitment from the sponsor to make sure that they are followed up properly,” temporary voting panel member James D. Heckman, MD, from Dartmouth-Hitchcock Medical Center in Lebanon, N.H., said. – by Casey Tingle
www.fda.gov/AdvisoryCommittees/Calendar/ucm489321.htm