FDA Clears Sculptor Robotic Guidance Arm™ For Unicompartmental Knee Replacement Surgery

Stanmore Implants ('Stanmore'), specialists in the design and manufacture of patient specific and modular orthopaedic implants, announced today that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Sculptor Robotic Guidance Arm™ ("Sculptor RGA™") for precision implant placement in unicompartmental knee surgery, also known as partial knee resurfacing.

Partial knee resurfacing only replaces the parts of the knee that are worn out and painful rather than cutting away the entire joint This preservation technique retains the natural ligaments around the knee, reduces surgical damage to tissue and is less invasive compared to total knee replacement. Sculptor RGA™ utilises a robotic guidance arm to assist the surgeon's operation of a cutting tool, limiting the removal of bone to a pre-defined safe area using Stanmore's patent protected 'Active Constraint™' technology.

Stanmore's unique personalised procedural approach to surgery seamlessly integrates advanced technologies. From proprietary planning software, personalised implants are designed in-house, then manufactured and placed precisely. During surgery, bone is removed corresponding to the implant shape whilst a tracking arm determines and monitors the location of the patient ensuring that the surgeon accurately prepares the bone surface to match the implant precisely.

This new and unique approach to the treatment of osteoarthritis of the knee has been used at a number of leading centres in the UK since the first patient specific personalised knee was implanted in July 2011 and builds upon the earlier clinical work undertaken using the Active Constraint™ technology featured in the Sculptor RGA™ device. Active Constraint™ technology has been shown to provide better functional outcome at 7 year follow up for partial knee surgery compared to the saws and jigs currently used in most knee surgery procedures, which are prone to a much higher degree of placement error.

The Sculptor RGA™ will be introduced in the United States for unicompartmental knee surgery in a limited release to a select group of surgeons from mid-2013, as Stanmore continues its evidence based approach to new product introduction. The Company is also developing additional applications for Sculptor RGA™ with the goal of broader commercialisation next year.

Brian Steer, Executive Chairman of Stanmore, said:

"Following this FDA clearance for Sculptor RGA™ we are excited by the opportunity to bring our personalised approach to knee surgery to patients in the United States. Robotic technology represents a major advance in orthopaedics, providing accurate placement that is critical to implant longevity and reproducibility along with tangible cost benefits, making access to robotic surgery more widely available to patients. Stanmore is now looking forward to working further with surgeons to continue to develop innovative solutions for the global orthopaedic market."

FDA Reduces Dosage Recommendations Of Sleeping Pills Containing Zolpidem

Manufacturers of sleeping pills with an active ingredient called zolpidem are being forced by the U.S. Food and Drug Administration (FDA) to reduce the current recommended dose of the medications. This measure comes following new evidence showing that the zolpidem blood levels of some people the day after taking the medications can severely impair their alertness and ability to perform tasks, such as driving or handling machinery.
Zolpidem remains in the blood the morning after taking it. By lowering the recommended dose of drugs with the ingredient inside, the blood level of zolpidem the morning after will be reduced. Women take longer than men to flush the ingredient from their system, the FDA has stated that the dosage for women will therefore be less than for men. Patients taking the extended-release forms of these drugs have the highest levels of the ingredient in their blood.

The FDA warns health care professionals of the importance in assuring that patients on these medications are completely aware of the risks associated with zolpidem.

For women, the recommended dosage of zolpidem found in instant release drugs (Edular, Ambien) will be lowered from 10 mg to 5mg, for extended-release drugs it will be lowered from 12.5 mg to 6.25 mg. Although men are able to eliminate the ingredient faster, the FDA still encourages doctors to consider prescribing the same dosages that are recommended to women.

According to Ellis Unger, M.D., director, Office of Drug Evaluation I in the FDA's Center for Drug Evaluation and Research:

"To decrease the potential risk of impairment with all insomnia drugs, health care professionals should prescribe, and patients should take, the lowest dose capable of treating the patient's insomnia. Patients who must drive in the morning or perform some other activity requiring full alertness should talk to their health care professional about whether their sleep medicine is appropriate."

Morning drowsiness and impaired alertness is not exclusively associated with zolpidem, the FDA reminded the public that there are many other insomnia drugs that also have the same side effect.

Those who are currently taking 10 mg or 12.5 mg doses of medications with zolpidem should carry on with their prescribed dose before talking to their doctor who will evaluate how to continue with the drug. People on the medication need to talk to their doctors to find an appropriate dose.

The change comes after a laboratory study and driving simulation revealed an increased risk of motor vehicle accident while zolpedim is still in a person's blood, as may occur the morning after taking some insomnia medications.

Dr. Unger. concluded:

"Over the years FDA has received spontaneous adverse event reports of driving impairment and motor vehicle accidents associated with zolpidem, but these reports lacked the information necessary to fully understand whether and how zolpidem affected people's mental alertness and ability to drive. Recently, data from clinical trials and other types of studies have become available, which allowed FDA to better characterize the risk of next-morning impairment."

More research will be carried out by the FDA to fully understand the risks of all the other insomnia drugs on the market.

A previous study published in Behavior Therapy revealed that in some instances, taking insomnia medication is not the best form of therapy in the long run, due to it's numerous side effects.