ConforMIS Inc. had a double-dose of good news today for its iTotal CR custom knee implant. The company touted CE Mark approval in the European Union as well as successful completion of the first surgeries using the knee resurfacing system.
Unlike standard implants, iTotal CR devices are based on an individual’s CT scans and tailored for their knee bones using computer-aided design.
The Burlington, Mass.-based company announced that it obtained CE Mark approval for the device early in May and that the first surgeries using the iTotal system were successfully completed in Boston, Houston and Indio, Calif., last month.
The iTotal system won 510(k) clearance from the Food & Drug Administration in February.
With this clearance, all ConforMIS products including the previously launched iUni and iDuo are FDA 510(k)-cleared and CE Marked, according to the release.
The ConforMIS total knee implants, designed for patients with knee damage from conditions such as osteoarthritis, are individually built using three-dimensional CT scans of the patient’s knee. Software corrects for deformities caused by joint damage and the implants are manufactured at the company’s Massachusetts facility and shipped to the site of the surgery.
Standard implants come in six or seven different sizes, meaning that surgeons must measure a patient’s bones after an incision to select the best fit, according to ConforMIS founder and CEO Philipp Lang.
“The challenge that you have with this technique is that the implant can never fit quite right,” he told MassDevice.
The key design rationale for the iTotal system is to make the patient’s new knee feel like their own knee, Lang said, noting that the technique avoids under-sizing, which can cause early failure, and implants that are too large, which can cause soft-tissue impingement and pain. The implant, because it’s “exactly fitted” to the patient’s joint, brings back the bone’s “natural curvature” to make it feel like a normal knee.
ConforMIS also has prototypes for other joints, but is rolling out the knee technology because of its market potential, Lang said.
Restorative Therapies Inc. announced FDA 510(k) clearance for its RT600 Functional Electrical Stimulation rehabilitation therapy system, which uses electrical currents to stimulate nerves which control leg muscles for patients with neurological injuries or paralysis, aiding in weight-supported stepping. The Baltimore, Md.-based company provides clinic and in-home restoration therapy systems.
Cardica Inc. (NSDQ:CRDC) touted CE Mark approval in the European Union for its Microcutter XPRESS 30, a surgical cutting and stapling device. The Redwood City, Calif.-based company expect first-in-man use of the device in Europe in the current quarter ending June 30.
Fujirebio Diagnostics Inc. announced an FDA nod for its CYFRA21-1 assay for monitoring lung disease. It’s the first biomarker assay kit to be cleared by FDA for use in the management of patients with lung cancer, according to the company. The Malvern, Pa.-based firm develops tumor marker assays for other malignancies, including breast cancer, ovarian cancer, and pancreatic cancer.
Medical Compression Systems (TLV:MDCL) won FDA clearance for its ActiveCare+Dx non-invasive device for "prevention and detection" of deep vein thrombosis. The company expects the device to enter the market this year.
MultiCell Technologies Inc. (OTC:MCET) landed a patent for its method of isolating and using human liver stem cells to treat liver disease. The firm is a clinical-stage biopharmaceutical company based in Woonsocket, R.I.
Orthocon Inc. won 510(k) clearance for its custom-designed applicator preloaded with Hemasorb, an absorbable bone hemostat matrix for stopping bone bleeding during surgery. The company touted CE Mark approval for the device in April.
Midatech Biogune, the nanoparticle manufacturing arm of the Midatech Group, won an Investigational Medicinal Products license from the Spanish Medicines Agency for its clinical-grade nanoparticles. SMA officials inspected the Midatech facility in Bilbao, Spain, in February.
Repro-Med Systems Inc. (PINK:REPR) announced an FDA nod for its RMS needle sets for the delivery of medication to subcutaneous tissue. The needles are already approved for Europe and Canada.