Medtronic Inc.’s (NYSE:MDT) Integrity coronary stent received pre-market approval from the Food & Drug Administration and logged its first U.S. implantation.
The Fridley, Minn.-based medical device giant based the bare-metal stent on its so-called "continuous sinusoid technology," which uses fewer welds than earlier stent models, such as the Driver, and a single wire of cobalt alloy.
The company designed the device to be more deliverable, or easier to insert. The stent’s first implantation, however, allowed it to exhibit its properties of comformability, according to Washington Adventist Hospital director of cardiac and vascular research Dr. Mark Turco, a Medtronic consultant, who performed the stent’s first implantation today.
Turco told MassDevice that the procedure involved a "bifurcation in the distal right corner artery" and while it didn’t significantly demonstrate the device’s deliverability, the operation "tested comformability in that it was an angulated right corner artery and that [the device] also allowed for good access into the side branch that was involved."
Conformability is a measure of the stent’s ability to conform to the natural shape of the vessel, according to Medtronic.
The Integrity stent is "going to hopefully allow Medtronic to have another drug-elution vehicle for their drug-eluting stent program," Turco said.
"It will be interesting to see whether this particular design helps with things like side-branch access and in treating bifurcation lesions," he added.
Medtronic won CE mark approval for the Integrity stent system in February and the device is available in approximately 100 countries outside the U.S. The company said the stent enabled the it to lead the bare-metal stent market in Western Europe and Central Asia.
A company spokeswoman said continuous sinusoid technology will serve as the foundation for Medtronic’s pipeline going forward. Medtronic announced the FDA approval and implantation today ahead of the 2010 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.