Guidant has won European approval for its Xience V drug-coated stent, keeping it on track to launch the product onto the market in the second quarter of this year.
Xience V (everolimus) will enter a market with just two rival drug-eluting stents at the moment, namely Johnson & Johnson’s Cypher (sirolimus) and Boston Scientific’s Taxus (paclitaxel), which together accounted for a global market estimated at $5.5 billion in 2005.
Xience V is expected to make inroads into the market for drug-eluting stents because it has a lightweight construction that makes it easier to deliver and deploy it into the diseased blood vessel. It has not yet been submitted for approval in the USA, however, which accounts for the majority of drug-eluting stent sales.
Guidant said a 1,380-patient trial called SPIRIT III will be used to support its application for approval of the stent in the USA and Japan. This is about 70% enrolled and should meet its target for patient numbers later this quarter, according to Guidant.
Approval is a welcome piece of positive product news for Guidant, which has been hit hard by a major recall of pacemaker and defibrillator products last summer that wreaked havoc with its revenues in the latter half of the year.
But the real beneficiary of the green light will be Abbott Laboratories, which is due to buy Xience V and the rest of the vascular business for $4 billion, as part of a $6.4 billion investment in Boston Scientific’s $27.2 billion acquisition deal for Guidant.