Navigation Links
FDA Approves First Artificial Cervical Disc

The U.S. Food and Drug Administration (FDA) has approved the first artificial cervical (neck) disc for the treatment of cervical degenerative disc disease , one of the most common causes of neck and arm pain.

The brand approved, the Prestige Cervical Disc, is manufactured by Medtronic Sofamor Danek of Memphis.

The approval of this artificial disc means that people with cervical degenerative disc disease now will have another surgical option for treating this condition," said Daniel Schultz, director, Center for Devices and Radiological Health, FDA. "This device will help relieve pain and restore function."

Cervical disc degeneration is a common cause of neck and arm pain that can greatly impact quality of life. The disc is a flexible material between the vertebrae that holds the bones together while still allowing for movement.

Because of the demands put on the disc, it sometimes can 'herniate' or wear down causing pain.

If treatments, such as rest, medications, physical therapy and activity modification are not successful, the standard surgical treatment is to remove the disc and then use a graft of bone and plate with screws to fuse the two vertebrae together.

The Prestige Cervical Disc would instead replace the impaired natural disc. It consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove). After a doctor removes the impaired natural disc, the artificial disc is attached to the adjacent vertebrae with bone screws.

FDA based approval on the company's laboratory and animal testing, and on its clinical study of 541 patients. The clinical study showed that the device improved neck and/or arm pain, and was as safe and effective as cervical fusion.

The approval decision also took into account the recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA's Medical Devices Advisory Committee, which reviewed the product in September.

As a condition of approval, the company will conduct a post-approval study over the next seven years to evaluate the longer term safety and effectiveness of the device.

FDA will continue to monitor the device as part of the agency's overall effort to ensure that products remain safe and effective once they reach the marketplace.


'"/>




Related medicine news :

1. FDA Approves Contraceptive Ring
2. FDA Approves New HIV Drug, Viread
3. FDA Approves Birth Control Skin Patch
4. FDA Approves New Arthritis Drug, Bextra
5. FDA Approves Elidel Cream for Eczema
6. FDA Approves New Anti-Clotting Drug
7. FDA Approves New surgery Treatment for Farsightedness
8. FDA Approves Anti-Cancer Cell Drug - Zevalin
9. FDA Approves Remodulin for Pulmonary Hypertension
10. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
11. World Health Organisation Takes a Historic Decision and Approves Treaty to Discourage Smoking
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/24/2017)... ... January 23, 2017 , ... The January 2017 issue of the ... study on how outdoor behavioral healthcare (OBH) – also known as wilderness therapy – ... while experiencing an increased sense of purpose both during and after treatment. , ...
(Date:1/24/2017)... ... January 23, 2017 , ... ... a new plugin that allows sleep centers to automatically connect and initialize all ... a thin client browser plugin is quickly installed on first use and then ...
(Date:1/23/2017)... Alto, CA (PRWEB) , ... ... ... a provider of translation and localization services for life science companies, has ... and inspection organization, TÜV SÜD America. ISO 17100 is the globally recognized ...
(Date:1/23/2017)... ... 23, 2017 , ... Wooden and plastic balance boards have been around since at least the ... Board is the first and only balance board to use a patent-pending design featuring ... at the same time as well as skill-level adjustable for all ages and abilities. ...
(Date:1/23/2017)... Indiana (PRWEB) , ... January 23, 2017 , ... ... Center for Assisted Living (IHCA/INCAL), will serve as a healthcare industry expert at ... 23. The panel discussion, moderated by Inside Indiana Business host Gerry Dick, will ...
Breaking Medicine News(10 mins):
(Date:1/23/2017)... Stock-Callers.com today presents the following Generic ... CPRX ), Sophiris Bio Inc. (NASDAQ: SPHS ), ... Therapeutics Inc. (NASDAQ: AGRX ). These companies are ... late trade on Friday, January 20 th , 2017, with ... of health care companies in the S&P 500 also were ...
(Date:1/23/2017)... , January 23, 2017 The global  anxiety disorders and ... by 2025. The rising incidence of depression worldwide is anticipated to drive the ... resulted in the declining demand for antidepressants in the recent years. ... ... Grand View Research Logo ...
(Date:1/23/2017)... DIEGO and PALMA, Spain ... Laboratoris Sanifit S.L., a clinical-stage biopharmaceutical company ... that the first patient has been enrolled in ... lead candidate, SNF472, for the treatment of cardiovascular ... (HD). Most ESRD patients, in the ...
Breaking Medicine Technology: