Medical Product Guide» Orthopedic products

Ascension Orthopedics Receives FDA Approval For TITAN™ Modular Total Shoulder System

Jim Marino — Fri, 24 Sep 2010 15:05:12 +0000

Ascension Orthopedics, Inc. announces FDA approval to market the TITAN™ Modular Total Shoulder System. This system redefines modularity by providing multiple surgical solutions for shoulder arthroplasty with one implant system. The TITAN Modular Total Shoulder System offers a bone-preserving option for patients needing total or hemi shoulder arthroplasty. The modularity of the system allows the surgeon to independently select distal stems and proximal bodies that best match the patient’s anatomy and bone quality.

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Mylan Receives FDA Approval For Nabumetone

Jim Marino — Fri, 16 Jul 2010 09:09:23 +0000

Mylan Inc. received the FDA approved for its generic version of the osteoarthritis and rheumatoid arthritis drug Nabumetone. The FDA approval allows Mylan to sell 500 milligram and 750 milligram tablets of Nabumetone. It is a nonsteroidal anti-inflammatory drug, which is a popular type of arthritis and inflammation treatment.

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FDA approves iFix Interference Screw System

Jim Marino — Fri, 29 Feb 2008 17:03:33 +0000

Cayenne Medical Inc. has received FDA clearance for the iFix(TM) Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures. These are the first FDA approved screws to hit the market that are made from polyetheretherketone (PEEK) plastic, which is radiolucent and highly biocompatible and has superior biomechanical strength. PEEK is a completely bio-inert material and, hence, screws made from this material do not result in foreign body reactions in patients.

Simulating scoliosis (spine) surgery

Jim Marino — Thu, 28 Feb 2008 18:14:38 +0000

Biomedical engineering researchers at the Queensland University of Technology (QUT) are working on developing a computer modeling program that would allow surgeons to simulate scoliosis surgery. This would enable surgeons to determine the most effective procedure before entering the operation theater. Professor Clayton Adam, a member of QUT’s Institute of Health and Biomedical Innovation (IHBI), said, “Spine surgery is one of the most complicated and painstaking operations because surgeons cannot afford to damage the delicate spinal cord.”

Glucosamine sulfate in doubt for hip osteoarthritis

Jim Marino — Wed, 20 Feb 2008 16:02:54 +0000

Glucosamine sulfate, a dietary supplement, is not more effective than a placebo in relieving pain for patients of osteoarthritis of the hip, according to a study led by Rianna Rozendaal and published in the Annals of Internal Medicine. The randomized two-year study was conducted on 222 people suffering from mild to moderate osteoarthritis of the hip, with half the group partaking 1,500 milligrams of glucosamine daily and the other half taking a placebo. The researchers concluded that the rate of improvement was insignificant between patients receiving glucosamine sulfate and those receiving the placebo. Critics said, however, that the study may have produced different results if it had been conducted for an additional year or if patients with more severe osteoarthritis had been studied.

Medtronic receives FDA approval for RestoreULTRA

Jim Marino — Mon, 11 Feb 2008 17:38:51 +0000

Medtronic Inc. has received FDA approval for RestoreULTRA, an implantable neurostimulation system device for the treatment of chronic, troublesome pain in the back and leg. Patients can adjust the stimulations produced by the rechargeable device according to fluctuations in pain through a remote control, apart from directing the stimulations at a specific point in the spinal cord. The company plans to make the device available in the U.S. by the end of February.

Demand for implantable devices estimated to rise 9.3% annually

Kate Wckswat — Mon, 28 Jan 2008 18:44:54 +0000

Despite the past few years’ product recalls and safety controversies, The Freedonia Group, Inc. estimates the demand for implantable devices will increase 9.3% annually in the US. Sales will reach $43.6 billion in 2011.

Driving the increased demand are shortcomings in existing drug therapies. In their place is a resurgence of cardiac and orthopedic implants; estimated to grow in demand at 9% and 8.8%, respectively. Cardiac implants represent the top seller of implantable medical devices, due to the prevalence of heart disease in the United States, and the extremely life-threatening nature of the disease itself.

Blood volume expander gets FDA OK

Melissa Chang — Sat, 29 Dec 2007 02:05:38 +0000

Voluven, an intravenous synthetic starch solution, has received FDA approval for use in surgery as a blood volume expander. Blood volume expanders are used to quickly restore some of the blood volume lost during surgery so that remaining red blood cells can continue to deliver oxygen to the body’s tissues. Voluven is manufactured by Fresenius Kabi, a German company.

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Zimmer knee gets FDA approval

Melissa Chang — Wed, 12 Dec 2007 16:57:19 +0000

Zimmer Holdings has received an approval from the Food and Drug Adminstration (FDA) for its mobile bearing knee, NexGen LPS-Flex Mobile Knee. The product is targeted for minimally invasive surgeries and is designed to extend active deep flexion for patients up to 155 degrees. The product is already being marketed in Europe, Australia and Japan.

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Minimally invasive hip stem implants released

Melissa Chang — Wed, 12 Dec 2007 16:42:10 +0000

Biomet Inc.’s orthopedics group has launched two new hip stems for minimally invasive total hip implants. The new products feature shorter stems, which are designed for proximal femoral bone fixation, while preserving more intramedullary bone than traditional length components. The products are called the Taperloc Microplasty Stem and the Balance Microplasty Stem.

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