Abbott’s Acculink stent trial met goals, FDA says

By Reuters
Posted Jan. 24 at 8:10 a.m.

Abbott Laboratories’ RX Acculink carotid stent appears to work as well as surgery in opening clogged neck arteries in patients who are not at high risk for complications from the surgical procedure, U.S. health regulatory staff concluded.

The device is already approved for patients who need to have their neck arteries opened up, but would face greater risk of side effects if they underwent a procedure to scrape off built-up fatty deposits that can cause strokes.

Abbott is seeking Food and Drug Administration approval to market its carotid stent for less-risky patients, saying it offers another choice.

On Wednesday, an FDA advisory panel will consider the request. The agency will later make the final decision.

Although doctors are already allowed to use the approved device as they see fit, formal FDA clearance would allow the company to legally promote wider use to physicians and patients and seek greater sales.

Such neck stents are a small part of Abbott’s vascular business, and the overall carotid stent market is currently growing at modest rates, Abbott Vascular spokesman Jonathon Hamilton.

“We anticipate an expanded indication and appropriate reimbursement would broaden the use of the product, potentially expanding the market over time,” he said.

In documents released Monday ahead of the panel’s meeting, FDA staff said the company-funded study, conducted in part by the National Institutes of Health, overall was able to prove that it was not any worse than the surgical alternative known as carotid endarterectomy surgery.

However, staff reviewers said when looking more closely at specific complications, stent patients had higher rates of death and stroke while surgical patients had a higher rate of heart attack.

In a separate memo, Abbott said the trial showed that its Acculink stent overall was no worse than the alternative surgery and that the trial “established a reasonable assurance of safety and effectiveness.”

Carotid stenting “is another treatment option for patients,” it wrote.

The trial, known as the Carotid Revascularization Endarterectomy vs. Stenting Trial or CREST trial, looked at the safety and effectiveness of stenting versus surgery in 2,502 patients and took nine years to complete.

Neck stents have raised some questions about which approach is better — stents or surgery. Stenting is a less invasive procedure than surgery and involves threading the wire mesh into the affected artery through a small incision.

In October, an analysis of 13 trials published in Achives of Neurology found using a neck stent is more likely to cause stroke or death compared to surgery, while surgical patients are more likely to have nerve damage and heart attacks.

Researchers have said both approaches work and overall have low rates of the differing complications. Which approach works best could depend on the patient, although it is unclear which individuals would be better suited to a certain therapy.

The FDA will ask its panel of outside experts on Wednesday whether the benefits of Abbott’s stent outweigh its risks.

Abbott’s Hamilton also said if FDA approves the wider use, the company will also seek expanded reimbursement coverage through the nation’s Medicare health insurance program for the elderly and disabled.

Shares of Abbott were up 0.4 percent at $48.11 in early afternoon trading on the New York Stock Exchange.

Other companies that also market carotid stent include Boston Scientific Corp, C.R. Bard Inc, Covidien’s ev3 and Johnson & Johnson.

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