Market & Industry Briefs

Article preview from Medtech Insight - February 1, 2011

Brief summaries of recent medtech market and industry developments. This month we cover expanded approvals for Abbott's RX Acculink Carotid Stent System and FDA's request for more data on MannKind's inhaled insulin device.

Market & Industry Briefs

Article preview from Medtech Insight - February 1, 2011

A US Food & Drug Administration (FDA) advisory panel late in January took a positive step toward expanding the approved indications for carotid stenting to lower-risk patients, voting 7-3 that the benefits of Abbott Laboratories Inc. 's RX Acculink Carotid Stent System outweigh the risks in both symptomatic and asymptomatic patients at standard risk for surgery. The devices are currently approved for use only in patients at high risk for surgery with at least a 50% stenosis if symptomatic or an 80% stenosis if asymptomatic. The proposed new labeling would substantially expand the patient pool, extending indications to standard-risk patients with a stenosis of at least 50% if symptomatic and at least 70% if asymptomatic.

The panel decision was based on outcomes from the landmark 1,321-patient Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which found comparable safety and efficacy between stenting and surgical endarterectomy in standard risk patients, both symptomatic and asymptomatic. Although overall outcomes were similar in the stent and endarterectomy patients, stroke rates in the trial were higher in the stented patients, presumably due to emboli released during the procedure. This raised some concerns among the panel members, who said physicians desiring to perform carotid stenting should first undergo a comprehensive training program, as the safety of the procedure appears to be largely dependent on physician experience and skill. The panel also recommended studies to assess stent durability and total mortality rates, and some panelists suggested monitoring patients more carefully in order to detect "silent strokes," small cerebral infarcts that have been linked to microemboli released during the carotid stenting procedure.

Acculink has been on the US market since 2004 and is one of several carotid stents now approved for use in the US. Other suppliers include Medtronic Inc., Cordis Corp./Johnson & Johnson, Boston Scientific Corp., and ev3 Inc./Covidien Ltd. However, limits on approved indications, reimbursement difficulties, and a lack of consensus among physicians about patient selection criteria have constrained the market.

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