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:6/24/2017)... ... June 24, 2017 , ... Dr. ... 217 Portion Road in Lake Ronkonkoma, Dental365 offers patients high-quality and affordable routine ... visits to the dentist fit into their patients’ busy lifestyles. Dental365 also gladly ...
(Date:6/23/2017)... ... 2017 , ... "The Better Care Reconciliation Act (BCRA) falls ... people with all chronic conditions, including mental illnesses, while increasing the cost of ... Care Act (ACA) requirement that insurers cover pre-existing conditions, it does not require ...
(Date:6/23/2017)... ... 2017 , ... The Military Officers Association of America (MOAA) announced its support ... retired Marine Col. Thomas G. Bowman. , Bowman currently serves as the staff director ... with the issues and challenges veterans face with the VA. Following a 30-year career ...
(Date:6/23/2017)... ... June 23, 2017 , ... Goodcents Deli Fresh Subs today announced the opening ... 4210 SW 21st St. Topeka, Kan. 66604 (near 21st and Gage). It is owned ... owns three other locations in the Topeka and Bonner Springs, Kan. area. , ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and South ... selected 21 leaders from government, business and civil society in 11 countries across the ... this fall, engaging in a transformative exchange of knowledge and ideas with the leading ...
Breaking Medicine News(10 mins):
(Date:6/7/2017)...  Diplomat Specialty Infusion Group, a brand of Diplomat Pharmacy, Inc. ... Iowa location. The Iowa ... an ISO 7 cleanroom—the standard needed to compound intravenous (IV) nutrition ... of pollutants. "Our new cleanroom ... serve our Iowa patients," said Phil ...
(Date:6/1/2017)... 2017 Nutriceutical Holdings (NH), parent company of ... and KD Pharma Group have decided to join forces ... Pharma Group. KD Pharma Group will become the largest ... the entire company. "We believe we have ... to growing the NH companies by providing us with ...
(Date:5/26/2017)... 2017  Endo International plc (NASDAQ: ENDP ) ... will represent the Company in a fireside chat at Goldman ... June 13, 2017 at 10:40 a.m. PT / 1:40 p.m. ... Rancho Palos Verdes, CA. ... be available on the Company,s website at http://www.endo.com/investors/overview . ...
Breaking Medicine Technology: