Silk Road Enroute to a larger market

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New data on Silk Road Medical’s Enroute stent might just be good enough to allow the product to become the standard of care for patients with a blocked carotid artery. The device and its delivery system were approved in the US in 2015 for patients at high risk of adverse events from carotid endarterectomy – the surgical removal of atherosclerotic plaque from the vessel. Registry data presented yesterday at the Society for Vascular Surgery’s annual meeting show that in standard-risk patients transcarotid artery revascularisation using Enroute has a similar risk profile to endarterectomy, with a significantly lower chance of cranial nerve injury. The data make a strong argument for increased adoption of this minimally invasive procedure in a wider population. Silk Road has already filed for approval in standard-risk patients, with analysts suggesting that a decision could come by early next year. Analysts believe that the number of carotid stenting procedures could jump from just over 14,000 so far this year to 120,000-135,000 per year. Enroute and its related accessories brought Silk Road $75.2m in revenue in 2020; should its sales grow proportionally to the expanded market, annual sales of Enroute could end up topping $600m.

Silk Road's Enroute stent in standard risk patients
  Enroute CEA  P value
N 4,993 14,979  
30-day stroke/death/myocardial infarction and one-year ipsilateral stroke (%) 2.6 2.6 0.89
30-day stroke (%) 1.4 1.3 0.75
30-day death (%) 0.3 0.3 0.73
One-year ipsilateral stroke (%) 1.3 1.2 0.48
All-cause mortality (%) 1.7 1.8 0.66
Cranial nerve injury (%) 0.3 2.7 0.001
CEA = carotid endarterectomy. Source: Society for Vascular Surgery & company release.

The Enroute carotid stenting procedure

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