said Wednesday that the Food and Drug Administration had approved a device to help kidney disease patients undergoing dialysis. The company will begin selling the device immediately.
The announcement helped the company's stock, which rose 84 cents, or 2.4%, to 36.62. The news was the latest among several positive reports from the Natick, Mass.-based medical device company, as it tries to recover from three recall announcements since early July concerning its Taxus drug-coated stent. The device improves the blood flow in arteries that have had artery-clogging plaque dispersed.
The recall announcements knocked the stock from the low $40s to the low $30s. Since mid-August, however, the stock has gained about 10%.
Boston Scientific is expected to discuss the financial impact of the recalls and its guidance for the third quarter during a teleconference call Sept. 1 for analysts and investors.
On Wednesday, the company said it received FDA approval to market its peripheral-cutting balloon microsurgical dilation device, which is used in treating patients suffering from end-stage renal disease. The disease occurs when both kidneys are impaired or are functioning at less than 10% of their normal rates. The Boston Scientific device helps doctors perform dialysis on kidney patients whose blood vessels may have become blocked or hardened.
Approval of the kidney device follows two other positive FDA actions in recent days.
On Monday, Boston Scientific said it had secured FDA approval for an updated version of a product used to treat saphenous vein graft, or SVG, disease. Heart surgeons use a portion of the saphenous vein, found in the leg, in bypass surgery. The vein is used to bypass damaged arteries; but these veins can harden and clog over time, increasing the risk of a heart attack.
To fix the problem, doctors resort to angioplasty, a procedure that clears obstructions from blood vessels. In angioplasty, a balloon-tipped catheter is inserted into the artery. When the catheter reaches the blockage, the balloon is inflated to push aside the artery-clogging plaque. The Boston Scientific product is a filter used to collect materials dislodged during angioplasty. If these materials enter the blood stream, they could create a clot and cause a heart attack.
Angioplasty also is used to help patients with end-stage renal disease, as it opens blocked blood vessels. But because this procedure can cause extreme pressure on the vessel walls when the angioplasty balloon is inflated, Boston Scientific says its new device for kidney patients carefully cuts away at the blood-vessel blockages allowing the balloon to dilate the vessel with less pressure. The device features tiny blades mounted on the surface of the angioplasty balloon.
And last week, the company reported that the FDA had approved extending the shelf life of the Taxus stent to nine months from six months, suggesting to some analysts that the series of recalls had ended. The shelf life for the Taxus stents outside the United States is still 18 months. However,
The Wall Street Journal
recently reported that the FDA still intends to inspect the Galway, Ireland, plant, which has been cited as the source of the manufacturing defect that led to the Taxus recalls.