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Rodney Brown on NECN: Hacking into medical devices
The U.S. Food & Drug Administration has given Boston Scientific Corp.’s new pre-mounted renal stent the thumbs up.
On Monday, the Natick-based medical device manufacturer announced the FDA had approved the Express SD Renal Monorail Premounted Stent System. The system is used as an adjunct for percutaneous transluminal renal angioplasty to treat lesions of the renal arteries.
Boston Scientific claimed in a statement that this is the first low-profile, pre-mounted stent for the renal arteries cleared for use in the United States. The company also claimed it was the only FDA-approved renal stent that provides additional proximal end support.
The company said that two-year results from the clinical trial on hypertensive patients with atherosclerotic renal artery stenosis indicated a “statistically significant improvement” in systolic blood pressure. For three-year results, there was no statistical difference in either diastolic blood pressure or serum creatinine levels from baseline. The nine-month results showed a binary restenosis rate of 21.3 percent, a target lesion revascularization rate of 8.1 percent, and no stent thrombosis.
Renal artery disease results when plaque forms in the arteries and reduces the main blood supply. Thereafter, the patient may develop high blood pressure or see kidney performance deteriorate. Treatments include surgery, medication or angioplasty. However after the angioplasty is performed, the artery can still shrink, and a stent is used as an adjunct treatment to re-open it, Boston Scientific explained in a statement.
Boston Scientific reported a 2007 net loss of $495 million on revenue of $8.4 billion.
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