Intermedics PMA for cementless Natural Knee is approvable -- FDA panel.
This article was originally published in The Gray Sheet
Executive Summary
INTERMEDICS ORTHOPEDICS PMA FOR CEMENTLESS NATURAL KNEE needs additional benchtop fatigue testing data before it can be approved, FDA's Orthopedic and Rehabilitation Devices Panel concluded at a June 12 meeting in Gaithersburg, Maryland. The request for enhanced fatigue testing data, which the panel said should include additional comparisons to other prostheses, was one of several conditions placed on the advisory group's unanimous approvable recommendation for the premarket approval application. The panel's recommendation covered cementless implantation of the Natural Knee in patients suffering from either inflammatory joint disease or non-inflammatory degenerative joint disease.
You may also be interested in...
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
World-First Nod For Yuhan's Lung Cancer Drug, In Korea
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes Gains US FDA Clearance For Velys Robot For Total Knee Surgery
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: