Stanmore Implants won FDA clearance for an extendible femur implant that can "grow" as the patient does, without the need for surgery, anesthesia or sedation.
The Juvenile Tumour System replaces large portions of the femoral bone in the thigh, which is sometimes removed during cancer treatment.
"Gaining approval in the key US market is a major achievement for Stanmore," said Stanmore executive chairman Brian Steer. "Having used the product for nine years in the European markets we are absolutely confident of the product’s ability to significantly improve patient outcomes and quality of life by negating the need for repeated surgery in children. This has very clear health economic repercussions and as such we look forward to introducing this product in the United States during the next few months."
The implant uses an electromagnetic device to lengthen the prosthesis, proving simpler and more cost-effective than painful lengthening or replacement surgeries. Each implant is customized for the individual patient.
In November 2002 a 13-year-old girl in the U.K. became the first to receive the JTS system. She has reached skeletal maturity with legs of equal length today, according to the company’s release.
More than 240 devices have been implanted in 15 countries since then.
Intelesens announced that its Aingeal wearable, wireless vital sign monitor won clearance from the FDA. The device allows continuous monitoring of a patient’s ECG, heart rate, temperature and motion without restricting the patient to a hospital bed.
"This has been a tremendous result following many months of meticulous testing and data gathering by the engineering and quality teams in Intelesens, who had to work very closely with the US regulatory authorities," said company CEO Michael Caulfield in the release.
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Sonitus Medical Inc. won a second 510(k) clearance for its SoundBite hearing system, a non-surgical and removable hearing device that transmits sounds via the teeth. The first clearance, obtained in March of this year, was for use with single-sided deafness. The second clearance clears use for patients with conductive hearing loss. The San Mateo, Calif.-based company plans to pursue clearance for an indication of mixed hearing loss.
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OMNIlife science Inc., a subsidiary of Orthopaedic Synergy Inc., won FDA clearance for their next-gen Apex PS Knee implant. The new design was introduced into the European market in the second half of 2010, and will be introduced into the U.S. market with a full launch expected by the end of 2011.
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Oticon Medical landed FDA clearance for their Ponto Pro Power device, a fully digital, programmable bone anchored power processor. The device increases the level of audibility for adults and children with severe hearing loss due to malfunctioning of the ear canal or middle ear and single sided deafness.
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MiMedx Group Inc. (OTC:MDXG) announced a trio of FDA clearances for its HydroFix line of biomaterial-based products, including the HydroFix Ortho Shield which is used for management of tendon injuries, preventing tissue attachment to the device while providing a protective environment for repaired tendons to heal.
"We are pleased to receive these FDA clearances," said chairman and CEO Parker "Pete" Petit. "Soft tissue attachments to repaired tendons can reduce the effectiveness of the repair and result in a reduced range of motion post surgery, so the HydroFix Ortho Shield meets an important clinical need. We are continuing to develop additional indications for this biomaterial in response to surgeon demand for a wide range of applications."
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