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FDA clears St. Jude Medical’s vascular plug to block abnormal blood vessels

St. Jude Medical (NYSE:STJ) announced Monday that the U.S. Food and Drug Administration has cleared a vascular plug for use in procedures that selectively block abnormal blood vessels. St. Jude Medical’s AMPLATZER Vascular Plug 4 can be used with a standard catheter in lieu of an embolization coil. As such, it is a first of […]

St. Jude Medical (NYSE:STJ) announced Monday that the U.S. Food and Drug Administration has cleared a vascular plug for use in procedures that selectively block abnormal blood vessels.

St. Jude Medical’s AMPLATZER Vascular Plug 4 can be used with a standard catheter in lieu of an embolization coil. As such, it is a first of its kind, the company said in a news release.

This type of vascular plug technology can now target smaller and difficult-to-reach blood vessels.

“With the AMPLATZER Vascular Plug 4 we now have the ability to use a diagnostic catheter to deliver the device, which means that patients in need of embolization of smaller, more tortuous vessels can benefit from this technology,” said Dr. Jafar Golzarian of the University of Minnesota Medical Center in Minneapolis, in the news release.

A St. Jude Medical executive also hailed the commercialization of the new product in the U.S.

“Approval of the AVP 4 represents a significant milestone for our U.S. vascular business,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “This technology simplifies the peripheral embolization procedure for physicians by eliminating the need for catheter exchanges and blocking or redirecting blood flow through the peripheral vessels in a more efficient manner than with surgical clips or embolic coils.”

However, an analyst said that he doesn’t think that the AMPLATZER Vascular Plug 4 is anything more than a line extension product.

“I do not see any significant impact,” said Thom Gunderson, a Piper Jaffray analyst, in an email. “This is a line extension product. As the large cap medtech companies get larger and larger, it is difficult for one single product to influence the stock valuation,” unless it is a new, exciting technology like Edwards Lifesciences’ SAPIEN transcatheter aortic valve replacement or renal denervation.

[Photo Credit: FreedigitalPhotos]