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Two employ collagen, the other sutures the site
Now, with three new devices, closing the femoral access site following diagnostic and interventional catheterizations can be done in three FDA-approved ways:
VasoSeal, manufactured by Datascope of Montvale, NJ, fills the tunnel with two successive plugs of purified cow collagen, which has been used in surgery since 1960 to help stop bleeding. The collagen overlays, but does not intrude into, the punctured artery. At the site of puncture, collagen biochemically stimulates clot formation while it mechanically blocks the hole. The device received FDA approval for sale in this country in September 1995.
AngioSeal, manufactured by Kensey-Nash of Exton, PA, uses collagen plus an internal plastic cork. The cardiologist uses a tube to insert a bit of plastic, shaped like a hat, into the artery. He pulls a string looped through the hat, drawing the hat up to its brim in the puncture. A biochemical seal is added by discharging collagen from the installation tube as it is backed out. The procedure takes two minutes. The hat and string, as well as the collagen seal, are degraded by the body within 90 days. The device was approved last August.
Perclose’s Prostar and Techstar systems fit into the femoral artery through a sheath, where the physician causes them to deploy the points of flexible needles. With a tug on the device handle, the needles penetrate the artery wall adjacent to the puncture. Outside the artery, a cylinder captures the needlepoints. The cardiologist pulls them out, each one trailing a suture, cuts away the needles, ties two square knots, and pushes the knots back down to the surface of the artery, sewing the hole shut. The devices provide immediate post-cath hemostasis without relying on the formation of a blood clot at the arterial access site. (See article, "How the suturing device works,")
The Prostar device deploys four needles and pulls two suture loops through the artery wall. The Techstar device deploys two needles and pulls one suture loop. The devices received approval in 1997 and have just acquired additional claims approval this spring.
The list price of VasoSeal is $195 and AngioSeal is $205. Prostar costs $325 and Techstar costs $225.
In addition, Vascular Solutions in Minneapolis has developed the Duett sealing device which takes a dual approach to arterial access site closure: A balloon catheter initiates hemostasis of the access site, then a natural procoagulant is delivered to form a permanent seal. The Duett sealing device is currently distributed in international markets while undergoing studies and awaiting FDA approval. At present Duett can only be used for clinical investigations.