Conformis Customized iTotal® Knee Replacement Shown to Significantly Reduce Risk of Adverse Events and Improve Discharge Status with No Increase in Hospital Costs Compared to Off-the-Shelf Implants
Clinical results of patients treated with Conformis iTotal® customized knee implants presented at the 2014 International Congress for Joint Reconstruction (ICJR)
Bedford, Mass. – July 18, 2014 – Conformis, Inc., a medical device company providing the only truly customized total knee implant, today announced results from a clinical study evaluating hospital outcomes and costs in patients undergoing total knee arthroplasty (TKA) using either Conformis iTotal® customized, individually made knee implants or standard off-the-shelf (OTS) implants. Results were presented today by Steven D. Culler, PhD, Associate Professor, Department of Health Policy and Management, Rollins School of Public Health at Emory University, at the 2014 International Congress for Joint Reconstruction (ICJR) Pan Pacific Orthopaedic Congress.
Researchers conducted a retrospective analysis of 248 TKA hospitalizations for patients having received either a Conformis iTotal customized knee implant (126) or a standard OTS implant (122) between March 2010 and November 2013. Patients with OTS implants demonstrated an adverse event rate of 13.9% while the Conformis rate was significantly lower at 1.6%. Data also showed that patients treated with Conformis customized implants had significantly lower blood transfusion rates of 2.4% compared with 10.7% for the OTS implants. Other studies have found that the average costs associated with blood transfusion is about $2,200 which coincides with higher risk of complications and longer hospital stays.1
An analysis of total hospital costs (excluding costs associated with discharge) found no statistical difference between the Conformis and OTS knee replacement. However, the study showed that significantly fewer Conformis patients were discharged to more costly acute care facilities (0.8% for Conformis vs. 7.4% for OTS). According to a recent study of discharge costs following TKA, the average cost of discharge to an acute inpatient rehabilitation facility was $16,464 on top of the hospitalization costs.2
“It is exciting that an important advance in medical technology can improve outcomes, shorten hospital stays and reduce the risk of adverse events while remaining cost neutral to the hospital,” said Stephen Culler, PhD, Associate Professor, Department of Health Policy and Management, Rollins School of Public Health at Emory University. “These findings indicate that patients were 4.9 times more likely to receive a blood transfusion and 10 times more likely to experience an adverse event with an off-the-shelf implant compared with a Conformis customized knee implant. I believe Conformis can present a number of significant advantages to patients, providers and payers without increasing hospital costs and while reducing the need for costly inpatient rehabilitation care.”
“Conformis iTotal was designed to address the shortcomings we see in today’s knee replacements which have a 20% rate of patient dissatisfaction,” said Philipp Lang, MD, MBA, Chairman and CEO of Conformis. “This study underscores the value that a customized implant provides by reducing the negative outcomes of total knee replacement without increasing, and likely decreasing, the overall cost to the healthcare system.”
About Conformis, Inc.
Conformis, Inc. is a privately-held medical device company that is pioneering a patient-specific approach to orthopedic implants and instrumentation. Its proprietary technology is supported by more than 375 patents and patent applications. Conformis’ award winning partial and total knee replacement solutions, the iUni® G2, iDuo® G2 and iTotal® G2, are individually designed for each patient. Potential advantages compared to traditional off-the-shelf implants include faster recovery, shorter hospital stay, less blood loss, more bone preservation, and better functional outcomes with more natural feeling knees. Conformis products are provided in a pre-sterilized single package delivery system that can help hospitals reduce costs and treat more patients by reducing instrument re-sterilization costs and shortening set-up, procedure and turnover times. The iUni® G2, iDuo® G2 and iTotal® G2, have been cleared by the U.S. FDA and are CE Marked in Europe.
Conformis is the leader in additive manufacturing in the orthopedic and medical device space. Conformis is the only orthopedic company that offers Just-In-Time (JIT) manufacturing with a single-package delivery system, resulting in greatly enhanced use of working capital.
Conformis technology is broadly applicable to all joints. The company is expanding into new applications and indications.
1. Szubski, et al; National Trends in Utilization and Outcomes of Allogenic Blood Transfusions in Primary Total Knee Artrhroplasty, 2000-2009. ISTA Annual Meeting 2013. Poster #2451
2. Ramos, et al; Correlation Between Physician Specific Discharge Costs, LOS, and 30-Day Readmission Rates: An Analysis of 1,831 cases. Journal of Arthroplasty; 2014, 29 #4: 674-677
New Clinical Study Finds Bilateral Knee Patients Prefer Conformis’ Fully Personalized Solution Over Competitive Off-the-Shelf Implants by a Factor of Over 10 to 1
Study included only patients with a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant
Conformis iTotal® CR Knee Replacement System Awarded “7A” Performance Rating from the U.K.’s Orthopaedic Data Evaluation Panel
Independently verified assessment of the performance of the fully personalized iTotal CR system over a 7-year period confirms that it meets the panel’s demanding standards