Makers of carotid stent systems received a major boost last month with the roll-out of a proposal by the Centers for Medicare & Medicaid Services to expand the population eligible for reimbursed carotid artery stenting.

Under Medicare’s current policy, patients with no symptoms of narrowing of the arteries but considered high risk for undergoing a carotid endarterectomy (CEA) procedure, are only covered when CAS procedures are performed in FDA Category B Investigational Device Exemption (IDE) trials, FDA-approved post-approval studies or in accordance with the Medicare clinical trial policy.

Under the proposed policy, asymptomatic patients under age 80, considered high-risk for this type of surgery and have 80% or greater carotid artery stenosis, would be eligible for coverage outside of a post-market study or clinical trial, as long as the procedure is performed using the FDA-approved carotid artery stent systems and embolic protection devices in a facility approved by CMS.

Medicare is also proposing to modify coverage for patients who are 80 and older because of “significant concerns regarding the safety of CAS” when performed in this older patient population, in order to improve the safety of such procedures.

This proposed decision would restrict coverage of patients age 80 and above only to those CAS procedures performed in Category B Investigational Device Exemption (IDE) trials, FDA-approved post approval studies, or in accordance with the clinical trial policy.

CMS said there will be a public comment period, with a final decision on the coverage expansion expected May 3.

Decision translates to dollars

The carotid stent market is currently valued at about $100 million in the U.S.

Several medical device makers have U.S. regulatory approval for carotid stenting, including Abbott Laboratories (Abbott Park, Illinois), Boston Scientific (Natick, Massachusetts), Johnson & Johnson (New Brunswick, New Jersey), ev3 (Plymouth, Minnesota) C.R. Bard (Murray Hill, New Jersey) and Cordis Endovascular, a division of Cordis (Miami Lakes, Florida).

Abbott, which banners itself as the market leader in the CAS market with two carotid stents, Xact and Acculink, said it played an instrumental part in securing the proposed expanded coverage decision. It said it made a formal request to CMS to revise the coverage decision and provided the agency with the data on which to make the expansion decision.

“Abbott is pleased that CMS is considering expanded reimbursement coverage for patients with carotid artery disease who are at high risk for surgery and who do not exhibit symptoms of stroke,” it said in a statement.

Abbott said it believes the impact of this decision represents a significant, positive impact — 50%-75% market growth; $50 million to $75 million on an annual basis.

While Boston Scientific said in a statement that it supports the proposed expansion, it also noted that it supports even broader coverage — all patients over the age of 80, without the IDE trial qualifier recommended by CMS.

“We are excited about the opportunity for expanded coverage for carotid stenting for asymptomatic patients at high risk for surgery,” said John Pedersen, president of Boston Scientific’s Peripheral Interventions business. “However, we believe that clinical data from our carotid stenting trials also supports expansion of coverage for high-risk symptomatic patients” — that is for those previously considered unable to withstand the surgery.

Pedersen noted that the CMS proposal comes on the heels of Boston Scientific’s launch of the NexStent carotid stent and the FilterWire EZ embolic protection system, “two products that utilize state-of-the art technology to address the need for stroke protection in high-surgical risk patients with carotid artery stenosis. We look forward to continuing to provide CMS with data to support even broader coverage of carotid stenting.”

The NexStent, developed by EndoTex Interventional Systems (Cupertino, California) -- which Boston Sci acquired last month — was FDA-approved in November and was studied in the CABERNET trial along with the company’s FilterWire EZ embolic protection system that received an FDA clearance for use in CAS in December.

Cordis bossts rapid exchange

Cordis Endovascular is one of the newest players in the carotid stenting derby. It recently received approval to market its Precise RX [rapid exchange] Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System to treat clogged neck arteries, and it is hoping that the rapid exchange feature of the stent will give it an edge.

It says RX versions of the CAS devices are quickly becoming an important niche in this market, saving physicians time during procures and requiring only one operator.

Dennis Donohoe, MD, VP of worldwide clinical and medical affairs for Cordis, told Cardiovascular Device Update that the Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System are different from Cordis’ over-the-wire carotid system approved last year. The RX, or rapid exchange version, only requires one physician operator because it is a shorter wire and the procedure time is also shorter, he said.

“Most physicians prefer the RX version because of the shorter length wire and because it does not require another physician,” Donohoe said. Once inside the patient, the device works the same as the company’s over-the-wire version and offers the same clinical results, he said.

The Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System are approved to treat carotid artery disease in patients at high risk for adverse events from carotid endarterectomy (CEA).

Other companies who have RX versions of carotid artery stents approved in the U.S. include ev3, Abbott and Boston Scientific. ev3 received FDA approval of its Prot g RX carotid stent in January.

Cordis is further bringing more data to this marketing dance, promoting the newly-approved system as the only one backed by a large, randomized clinical trial — the SAPPHIRE study — to support the potential benefits of CAS in patients who are ineligible, or considered high-risk, for carotid endarterectomy.

“No other carotid artery stent and embolic protection system has been studied as extensively in as wide a range of high-risk patients as the Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System and we intend to continue building upon this important body of clinical evidence,” Donohoe added.

Anil Chhabra, MD, of Willis Knighton Medical Center (Shreveport, Louisiana), performed the first carotid case with the Precise RX Nitinol Self-Expanding Stent and Angioguard RX Emboli Capture Guidewire System in the U.S.

Cordis Endovascular also reported the initiation of Sapphire Worldwide, a 10,000 patient global registry to assess the 30-day rate of major adverse events (death, stroke or myocardial infarction) following the placement of a stent in high surgical risk patients with carotid artery disease.

The stent procedure includes use of an emboli distal protection system — designed to contain and remove plaque or debris from the artery during the procedure. The registry will include up to 275 centers with low, medium and high annual carotid stent implant volumes, from both academic and private hospitals.