Abbott Laboratory's RX ACCULINK Carotid Stent System outweighs its risks and patients with symptomatic and asymptomatic carotid artery diseases at standard surgical risk should be included in its usage, an FDA (Food and Drug Administration) Advisory Committee voted today; 7 in favor, 3 against and 1 abstention. At the moment, the stent is only approved for use with symptomatic and asymptomatic patients at high risk of adverse events from surgery (carotid endarterectomy).

The Advisory Committee's (The Panel's) recommendation is not binding. However, the FDA nearly always goes along with its advice. Abbott believes the Agency will make a decision later this year to expand the current indication to include individuals at standard risk.

Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular, said:

"After a thorough review of the scientific evidence, we are pleased that the advisory committee concluded that less-invasive carotid artery stenting is as safe and effective as surgery for patients at standard surgical risk. If the FDA approves an expanded indication, carotid artery stenting would represent an important additional option for physicians as they work with their patients to determine the best individualized treatment approach."

The Panel examined data from the Carotid Revascularization Endarterectomy vs. Stenting Trial, also known by its initials CREST - the largest prospective trial ever to compare surgery to stenting.

As far as stenting versus carotid surgery is concerned, the trial showed that safety and long-term outcomes were comparable for those with symptomatic and asymptomatic carotid artery disease who were at surgical risk.

In a communiqué, Abbott wrote:

"In an analysis of 2,307 standard-risk patients with symptomatic and asymptomatic disease, carotid artery stenting demonstrated non-inferiority to surgery for the primary composite endpoint of death, any stroke and myocardial infarction (heart attack) within 30 days of the procedure plus ipsilateral (same side) stroke from 31 to 365 days. The results showed 7.1% of stenting patients and 6.6% of surgery patients experienced an event, the difference being non-significant."

The RX ACCULINK Carotid Stent System is used alongside the RX Accunet Embolic Protection System. It is designed to treat individuals with a high risk of adverse events from carotid endarterectomy who need carotid revascularization and meet certain criteria.

The stent was created as an alternative procedure to surgery. In surgery the artery leading to the brain is cut open and plaque formations that can block blood flow are scraped out. In stenting, the stent is inserted through an incision in the leg and threaded up to the target area, it is then expanded (like a balloon) to widen the artery, resulting in better blood flow.

"RX ACCULINK Carotid Stent System "

Source: FDA, Abbot Laboratories



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