Navigation Links
FDA Clears Critical Limb-Saving Vascular Device

The U.S. Food and Drug Administration (FDA) today cleared for U.S. marketing a vascular shunt, a medical device that can help save the arms and legs of soldiers critically injured// in combat as well as individuals in other trauma settings and emergency situations.

FDA reviewed the Temporary Limb Salvage Shunt (TLSS), made by Vascutek Ltd. (Renfrew, Scotland), in less than one week because of the critical need for such a device.

"This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. "This device has been used successfully by other countries, and is particularly important to serve our men and women in the Armed Forces who are seriously injured in combat."

The device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb. It can be implanted on the battlefield and other remote areas to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb until the patient can be transported to a surgical facility.

The TLSS is a tube formed from two layers of plastic. The device has several features that optimize its use in a trauma situation, including a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; beveled ends that facilitate quick and effective placement of the device within the severed blood vessel; graduated markings that provide visual confirmation of proper device placement; and extra reinforcement in the center of the device so it can be cut to a shorter length if needed.

To facilitate this accelerated review process, the device manufacturer worked in close collaboration with FDA's Division of Cardiovascular Devices after discussion of the need for the device with the U.S. Air Force. There are currently no other devices specifically available for treating injuries of this nature.

Source-Bio-Bio Technology
SRI
'"/>




Related medicine news :

1. Baby Acne Clears Up On Its Own
2. SC Clears Deck For Implementation Of Nutrition Scheme
3. Bangkoks Public Health Ministry Clears The Northern Province Of Bird Flu Epidemic
4. Cabinet Clears Purchase Preference Policy for Pharma PSUs
5. European Commission Clears Diabetic Insulin for Pregnant Women
6. Delhi Government Clears Healthcare Projects Worth Rs.1.13 bn
7. FDA Clears Breast Cancer Specific Molecular Prognostic Test
8. Ultrasound Screening Could Improve The Outcome Of Critically ill Patients
9. Sleep Not Critical For Early Brain Development Of Baby Dolphins
10. Critically Ill Patients More At Risk Of Infection If Glucose Is Present In Their Lung Secretions
11. Dietary supplementation of Folic Acid Requires Critical Evaluation
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading ... to advocate for action towards gender equality at their inaugural Summit in New York ... globe, and reached a social audience of over 3 million. To watch the Mobilize ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the ... published author, William Nowers. Captain Nowers and his wife, Millie, have six children, ... in the Navy. Following his career as a naval aviator and carrier pilot, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... Sept. 28, 2017 Hill-Rom Holdings, Inc. (NYSE: ... conference call and webcast on Friday, November 3, 2017, ... and ending at approximately 8:30 a.m. (CDT) / 9:30 ... company,s 2017 financial performance and guidance for 2018, Hill-Rom ... to enhance operational performance, and long-range financial outlook through ...
(Date:9/27/2017)... -- Commended for their devotion to personalized service, SMP Pharmacy Solutions ... in the South Florida Business Journal,s 50 Fastest-Growing Companies, and ... the national specialty pharmacy has found its niche.  To that ... be honored by SFBJ as the 2017 Power Leader in ... receive his award in October, Bardisa said of the three ...
(Date:9/25/2017)... --  Montrium , an industry leader in powerful ... Trial Master Files & Inspection Readiness Conference ( ... Services has selected eTMF Connect to ... a leading European contract research organization (CRO), will ... enable greater collaboration with sponsors, improve compliance and ...
Breaking Medicine Technology: