Navigation Links
FDA Approves Device to Maintain Blood Flow During Artery Bypass Brain Surgery
Date:3/10/2011

SILVER SPRING, Md., March 10, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a surgical kit that allows neurosurgeons to reroute blood flow around an aneurysm or a tumor in the brains of patients at greater risk of stroke during standard bypass surgery.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The ELANA (Excimer Laser Assisted Non-Occlusive Anastamosis) Surgical Kit allows neurosurgeons to create a bypass without shutting off the blood flow. It consists of a small platinum ring and a hand piece connected to a surgical laser and suction tubing.

Standard bypass surgery in the brain requires clipping the artery to halt blood flow during the procedure. The surgery is not considered safe for about 1,000 patients annually in the United States because temporarily shutting off their blood flow would put them at high risk of stroke. The group  includes patients ages 13 and older who have an enlarged, weak area in a brain artery (cerebral aneurysm), tumors at the base of the skull that could impact blood flow in brain arteries, or other issues that could complicate conventional surgery.

"The ELANA Surgical Kit may help those with a rare condition for whom there previously was no treatment option," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.

To create the bypass, a surgeon sutures the ring and a section of replacement blood vessel onto the surface of the affected artery. Once attached, the surgeon tunnels the tip of the laser handpiece down the open end of the replacement blood vessel until the tip of the laser touches the ring.

The laser then cuts a circular hole in the affected artery, and suction removes the cut tissue. The process is repeated with a second replacement blood vessel. Once both replacement blood vessels are in place, the open ends of the two replacement blood vessels are sutured together to complete the path around the aneurysm or tumor.  

The FDA approved the ELANA Surgical Kit as a Humanitarian Use Device, which is a device that is designed to treat or diagnose a disease or condition in fewer than 4,000 people in the United States each year. To obtain approval for humanitarian use, a company must demonstrate the safety of the device and that the probable benefit outweighs the risk of illness or injury. The company must also show that no comparable devices are available to treat or diagnose the disease or condition.

The clinical data in support of approval demonstrated that a bypass created using the ELANA kit had the same types and similar incidences of adverse events reported in the medical literature as conventional bypass procedures.

A patient should not undergo laser bypass surgery using the Elana kit if the arteries show signs of arteriosclerosis or calcification at the surgery site, the walls of the affected artery are thicker than a carotid artery, or have an abnormality. Bypass surgery with the Elana should not be done on an aneurysm or on vessels other than large (> 2.5 mm), intracranial arteries.

In some cases, the laser does not completely cut through an artery wall leaving a tissue flap that potentially could block blood flow and result in an embolism. As part of the approval, the FDA required a post approval registry study to collect performance information about the kit, including flap retention rate, mortality, and stroke.

The ELANA Surgical Kit is manufactured by Elana, in Utrecht, Netherlands.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/19/2017)...  Mako Medical Laboratories partnered with Secretary Strickland, the ... Fund (MFA) to bring 140 soldiers back home to ... families one last time before being deployed. Mako Medical ... logistics needed for these soldiers. "Mako Medical Laboratories is ... We just wish we could bring them all home," ...
(Date:7/13/2017)...  Centurion Medical Products, a leader in medical product innovation and ... removal device for hospice patient care. ... Centurion Medical Products ... Patient pain management and emotional comfort are part of a ... pain while preventing unneeded emergency department admission due to severe fecal ...
(Date:7/11/2017)... , July 11, 2017 Zymo Research Corp., also known ... that can quantify biological aging in a precise manner using the myDNAge ... Steve Horvath , a professor of human genetics and biostatistics at the ... School of Public Health , Zymo Research,s proprietary DNAge ™ technology ... ...
Breaking Medicine Technology:
(Date:7/21/2017)... ... July 21, 2017 , ... Thomas Jefferson ... Witness , was awarded a $300,000 grant from The Pew Center for Arts ... with ambiguity and the recognition of one’s own limits among health professions students. ...
(Date:7/21/2017)... ... July 21, 2017 , ... ... $5,000 grant from the C. R. Bard Foundation, Inc. to support ... Hills , a service available through the nonprofit home care agency. Using evidence-based ...
(Date:7/21/2017)... ... 21, 2017 , ... In the first prospective ACL reconstruction ... Outcome Network (MOON) demonstrated that patients could perform sports-related functions and maintain a ... over time. The study, presented today at the American Orthopaedic Society for ...
(Date:7/20/2017)... MA (PRWEB) , ... July 20, 2017 , ... ... form of blood and bone marrow cancer that progresses rapidly without treatment. Newly ... recommended to reduce the chance of reoccurrence and relapse. With such a ...
(Date:7/20/2017)... ATLANTA, Ga. (PRWEB) , ... July 20, 2017 , ... ... and equal access to medicine for everyone affected by diabetes, is teaming up with ... the five-day global event kicks off on July 24th. , “Team Type 1’s ...
Breaking Medicine News(10 mins):