Pharmacy Drugs
Recent Posts
- EPIX Pharmaceuticals Announces FDA Approval Of A Physician-Sponsored IND For Fourth 6-month Open Label Extension Of PRX-03140 For Alzheimer’s Disease
- Miriam Hospital Researcher Receives More Than $12 Million To Study Weight Control
- Novel HIV Drug To Be Studied In Cell Cultures And Patients
- ISCTM Meeting Discusses Clinical And Regulatory Aspects Of Using Adaptive Designs In Clinical Trials For Central Nervous System Drug Approvals
- Evaluation Of The Cost Effectiveness Of Implantable Blood Pressure Device
Random Posts
- Safety And Cognitive Stability Are Key Findings In Phase IIA Trial Of New Alzheimer's Disease Treatment From Humanetics Corporation
- Results From 3 Phase 2 Studies Reported A Two-Year Survival Rate Ranging From 30 To 42 Percent In Metastatic Melanoma Patients Treated With Ipilimumab
- Is It Legitimate To Stop Clinical Trials Early On Account Of Their Opportunity Costs?
- Australian Study Suggests Rainwater Is Safe To Drink
- PEAK Surgical Announces First Use Of PEAK PlasmaBlade(TM) In Europe
- Royal Pharmaceutical Society Leads Call For Original Pack Dispensing
- Study Finds Estrogen Receptor-Negative Tumors Have Vaccine Targets
- Professor Finds Strong Link Between Counseling Approach And Relationship Success
- Spectranetics to Pay $5M in Federal Settlement
- Ian Facer Is New Chairman Of The National Pharmacy Association (NPA), UK
FDA Okays Ankle Replacement Device
Posted by: admin in Pharmacy Drugs on May 31st, 2009
WASHINGTON, May 28 — The FDA has approved a system for replacing ankle joints deformed by arthritis that may preserve a greater range of motion than fusion surgery.
The Scandinavian Total Ankle Replacement (STAR) system, manufactured by Small Bone Innovations, is a mobile-bearing device consisting of two metal plates with bars that fit into the bone and a polyethylene spacer that moves between the plates like a ball bearing.
It is the “first of its type,” according to the FDA, which has approved several fixed-bearing devices in which “the articulating surface is molded, locked, or attached to one of its metallic components.”
The STAR system “more closely imitates the function of a natural ankle,” according to Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.
It represents an alternative to fusion surgery, which involves cementing the tibia to the talus bone in the ankle, reducing the ability to move the foot up and down.
The approval was based, at least in part, on a study of 224 patients who were followed for at least two years. Those who were fitted with the STAR system had rates of adverse events, surgical interventions, and major complications similar to those in patients who had fusion surgery, according to the FDA.
As a condition of the approval, the device maker must evaluate the safety and effectiveness of the device over the next eight years.
| Copyright 2009 |
online pharmacy ambien no prescription buy xanax online no prescription online tramadol buying xanax online buy soma