St. Jude gets clearance for vascular plug

The AVP4 is the first vascular plug inserted with a standard diagnostic catheter--courtesy of St. Jude

St. Jude Medical ($STJ) is expanding its cardiovascular offerings with the launch of the Amplatzer Vascular Plug 4, just cleared by the FDA.

AVP4 is the latest in St. Jude's line of vascular occluders, and the company says the new model is designed for transcatheter embolizations--minimally invasive procedures that target specific blood vessels to block. The device's big sell, according to St. Jude, is that it can be inserted using a standard diagnostic catheter, unlike any other plug on the market. That allows doctors to treat hard-to-reach blood vessels with precision and speed, the company said.

The tech is the next step in vascular plugs, said Frank Callaghan, president of St. Jude's cardiovascular division, but it's also a boost to the company's portfolio. "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," he said in a statement.

AVP4 got its CE mark in 2009 and has been on the market in Europe ever since. St. Jude acquired the Amplatzer line in its 2010 buyout of AGA Medical for $1.3 billion

Earlier this year, the FDA requested a re-analysis of a previous Amplatzer occluder, which, in 10 years on the market, had resulted in cardiac erosion in fewer than .1% of patients within a year of getting the implant. A small number, the FDA acknowledged, but still an alarming result, and St. Jude has said it will comply and re-examine the related data.

- read St. Jude's statement
- check out a video of how AVP4 works

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