Guidant gets FDA approval for Lifestream:
This article was originally published in Clinica
US cardiology company Guidant has received US FDA approval to market its ACS over-the-wire Lifestream coronary dilatation catheter. Advanced Cardiovascular Systems, part of Guidant's vascular intervention group, manufactures the device and distribution of the product will begin at once. Guidant says the ACS OTW Lifestream has a 26% reduced crossing profile compared with the ACS Stack 40S catheter and allows physicians to reach and cross more difficult lesions.
You may also be interested in...
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.
Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.