Medtronic gets FDA approval for “essential” stent

A new type of stent described as fulfilling an “essential need” has been approved by the FDA. Produced by Medtronic, the Micro-Driver coronary stent is a bare metal system designed specifically for use in small vessels and patients with “tortuous anatomies”.

Medtronic says the stent is the first bare metal stent for small vessels with an indication for new or untreated vessels. It is designed so that the stent can access difficult-to-reach lesions in patients with small vessels. The company adds that many surgeons still favour bare-metal stents for some procedures, despite the increase in drug-eluting stents.

Sean Salmon, Medtronic vice president and general manager of Medtronic Vascular’s coronary business, said: “A stent can be effective only if it gets to the lesion. We believe there always will be an important role for bare metal stents, especially when they can address specific clinical needs as this stent does.”

The Micro-Driver stent is made from a cobalt alloy and it replaces the S660 stainless steel model. Stents are mainly associated with coronary care but they can be used for other vessels and ducts in the body, such the oesophagus, bile duct or urethra.

The British Heart Foundation says that 39,000 angioplasties are carried out each year in the UK, in most cases necessitating the use of a stent. It says that sometimes bare metal stents are prone to tissue growth around the metal, which can block the vessel again – something designed to be prevented by the use of new drug-eluting stents.

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