Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, Stephen Ferguson, of Bloomington, Ind.-based Cook Group Inc., cited several problems he saw with the draft, including that one of the specifications for balloon fatigue testing exceeds the level spelled out in an international standard adopted by the FDA.
The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization.
The controversy over paclitaxel (PCT)-associated mortality in devices for the peripheral arteries is far from over, but another medical journal article has punched a hole in the credibility of the paclitaxel theory with the conclusion that the evidence is unequivocal and may be unpersuasive to physicians.
Surmodics Inc., of Eden Prairie, Minn., said the U.S. FDA has granted a breakthrough device designation to its Sundance sirolimus-coated balloon (SCB) catheter to potentially help those suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease.
LONDON – There is no evidence for increased mortality in patients receiving paclitaxel-eluting stents and drug-coated balloons (DCBs) to treat peripheral arterial disease, according to the largest real-world safety analysis to date. The findings may come as a relief to many, particularly after a meta-analysis published in December 2018 led to safety warnings and restrictions on the use of coated and drug-eluting devices.
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