ConforMIS (NSDQ:CFMS) said yesterday that results from an ongoing 300-patient study of its iTotal CR knee replacement system indicate a high rate of satisfaction among individuals implanted with the system.
Results from the multi-center, prospective study were presented at the 2016 SICOT International Orthopedic “Specialized Knee Surgery” Conference in Wurzburg, Germany last week.
“A satisfied patient is the ultimate goal of knee replacement. A growing body of clinical evidence continues to support my belief that customized implants improve important patient outcome measures like patient satisfaction. With the ConforMIS iTotal CR, I’ve seen a meaningful shift towards happier, more satisfied patients,” study investigator Dr. Gregory Martin said in a prepared statement.
An interim data analysis reported that 92% of patients were satisfied, on average, at 1-year post operation, compared to 80% of patients who receive off-the-shelf total knee replacements, the company said.
“We are seeing a growing body of evidence in multiple clinical studies that patients receiving ConforMIS iTotal CR implants demonstrate better functional outcomes and objective outcomes than patients receiving off-the-shelf implants. Improved patient satisfaction and better quality care are the essence of what we strive for as we continue to innovate and bring new products to the joint replacement market,” CEO Dr. Philipp Lang said in prepared remarks.
Additional data also presented at the conference indicated that patients implanted with the iTotal CR showed statistically significant improvements from baseline pre-operative scores across spectrums of pain, symptoms, activities of daily living, recreation and quality of life, ConforMIS said.
In May, ConforMIS shares slid after the medical device company said it’s withdrawing its bid for FDA clearance for the iTotal personalized hip replacement after the federal safety watchdog raised questions about the bid.
Bedford, Mass.-based ConforMIS said the FDA raised “a number” of questions about its 510(k) clearance application – too many for the company to answer in the allotted review time. The company said it plans to answer those questions, “including conducting any associated testing,” in time for a new submission during the 2nd half of the year.
