Navigation Links
FDA approval of brain aneurysm device gives Jefferson neurosurgeons another life-saving tool
Date:4/18/2011

PHILADELPHIA The recent U.S. Food and Drug Administration (FDA) approval of a brain aneurysm device has opened the door for neurosurgeons at Jefferson Hospital for Neuroscience (JHN) to offer advanced treatment to patients suffering from large or giant aneurysms who otherwise have limited, effective options.

"With this FDA approval, the team of neurosurgeons here at JHN has a better tool to block and shrink these types of aneurysms, saving lives and vision in some cases," said Fernando Gonzalez, M.D., assistant professor in the Department of Neurological Surgery, Division of Neurovascular Surgery and Endovascular Neurosurgery at JHN, who performed the procedure using the stent, known as a Pipeline Embolization Device (PED).

PED is a flexible mesh tube made of platinum and nickel-cobalt chromium alloy that blocks off large, giant, or wide-necked aneurysms in the internal carotid artery, a major blood vessel supplying blood to the front of the brain. It also reduces the chance of rupture and eliminates the need for invasive surgery.

Prior to the FDA approval, Dr. Gonzalez used PED under "compassionate-use" exemption to treat four life-threatening aneurysms in a procedure done at JHN, the region's only facility exclusively dedicated to neurology and neurosurgery. Jefferson is the first hospital in Pennsylvania, New Jersey and Delaware to use the device on a patient.

The FDA decision now allows Jefferson's renowned team of vascular neurosurgeons, who are among the busiest in the nation performing both open and endovascular procedures, to offer better treatment to other patients in this subset (about 10 percent of the 30,000 brain aneurysms cases in the United States per year) who wouldn't benefit from coils or traditional stents because of the size of their aneurysm.

"Numerous studies have shown that in certain types of surgery experience, the number of cases a surgeon and an institution perform has an impact on quality and patient outcomes," said Robert H. Rosenwasser, M.D., chairman of the Department of Neurological Surgery at Thomas Jefferson University. "Volume does matter, and it clearly matters for patient outcomes in neurosurgical cases for brain tumors, vascular and endovascular procedures, spinal surgery and for both surgical and medical treatment of stroke."

"JHN easily ranks in the top five for each of these treatments," he adds.

Dr. Gonzalez, who is one of the few people with experience with the device on the East Coast, used the PED on a Jefferson patient who had four aneurysms on her carotid and ophthalmic arteries. Open surgery wasn't an option because the patient was on blood thinners for Sickle Cell Anemia, so Dr. Gonzalez filed for paperwork with the FDA for "compassionate-use" of the device. The procedure was approved and performed with great successthe aneurysms have since completely disappeared.

"Because of our experience in endovascular treatments and with the device we are going to be proctors nationally as the PED is rolled out," Dr. Rosenwasser said.


'/>"/>

Contact: Steve Graff
stephen.graff@jefferson.edu
215-955-5291
Thomas Jefferson University
Source:Eurekalert

Related medicine news :

1. Novel immunotherapy drug receives FDA approval for the treatment of metastatic melanoma
2. Speedy generic approval may not benefit consumers as much as expected, Rotman model shows
3. Speedy generic approval may not benefit consumers as much as expected, Rotman model shows
4. Cancer-targeting investigational nanoparticle receives FDA IND approval for first-in-human trial
5. SNM applauds FDA advisory committee recommendation for approval of Alzheimers imaging agent
6. FDA Advisers Consider Approval of Genetically Modified Salmon
7. FDA Advisers Weigh Approval of Genetically Modified Salmon
8. FDA Panel Votes Against Approval of Female Viagra
9. Mr. Dad and GreatDad.com Salute Fathers and Families with This Spring's ‘Seal of Approval' Picks
10. US Department of Education Financial Aid Approval
11. Hydroponics Nutrients For Medical Marijuana Gain Government Approval
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/25/2017)... ... April 25, 2017 , ... ... modern procedure that achieves results in a fraction of the time as traditional ... NV, with Significance Dental Specialists, now offers this revolutionary treatment with or without ...
(Date:4/25/2017)... ... ... Back Pain Centers of America (BPC), which connects people searching ... area, announces the launch of a new and proprietary customer relationship management (CRM) system ... physicians to help them with back or neck pain and helps to match them ...
(Date:4/25/2017)... ... April 25, 2017 , ... Somnoware, ... to its patient care management module. Using this new feature, sleep physicians can ... been initiated on continuous positive airway pressure (CPAP), oral, or other forms of ...
(Date:4/25/2017)... ... April 25, 2017 , ... ... healthcare products, is introducing Flexadin UCII, part of the EQUISTRO line, at this ... joint health in horses at the immunologic level. , The scientifically-developed Flexadin UCII ...
(Date:4/24/2017)... (PRWEB) , ... April 24, 2017 , ... ... technology yesterday, featuring Bring Your Own Device (BYOD) capabilities at Telehealth 2.0, the ... CNS’ pre-packaged telehealth bundles, which pairs medical devices with a pre-programmed tablet in ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... Research and Markets has announced the addition of the ... Service (Manufacturing, Research), By Country, (Brazil, Mexico, Colombia, Argentina, Chile, ... their offering. ... Latin American pharmaceutical contract manufacturing services market is anticipated to ... registration cost in Latin American countries and continuous economic growth ...
(Date:4/19/2017)... , April 19, 2017  IRIDEX Corporation (Nasdaq: ... release financial results for the first quarter 2017 after ... The Company,s management team will host a corresponding conference ... ET. Investors interested in listening to the ... for domestic callers or (703) 326-3030 for international callers, ...
(Date:4/19/2017)... The Global Effective Microorganisms (EM) Market by Manufacturers, ... and analysed the potential of Global Effective Microorganisms (EM) Market ... growth factors. The report identifies and analyses the emerging trends ... market. ... and Figures, 6 Major Company Profiles, spread across 124 pages ...
Breaking Medicine Technology: