| 医疗器械 |
2013-12-14 14:08 |
2013年10月11日讯 /SciFans.net/ --Cook医药公司研发的Zilver PTX于今年四月份被美国FDA宣布召回，这一决定距Zilver PTX获得FDA通过仅仅过去了数月之久。现在，Cook公司再次在该设备的实验中取得了理想结果。这一横跨美国、欧盟和日本的研究为其四年，有479名患者志愿参加。Zilver PTX就其治疗外周动脉疾病的疗效而被跟踪研究。实验表明，75%的使用了该产品的患者病情有明显改善，而对照组仅为58%，同时在使用Zilver PTX四年后，83.2%的患者不必在接受血管再生术的治疗。Zilver PTX在去年11月获得FDA批准，成为第一种获批治疗外周动脉疾病的药物洗脱支架产品。但几个月之后Cook公司发现在极少数病例中，输送导管会脱离所固定的血管。
而这项最新的研究成果使得Cook公司有信心重新获得FDA的青睐。（SciFans.net）
详细英文报道：
Coming off an FDA recall in April just months after winning U.S. approval, Cook Medical has had a lot to prove to drag its Zilver PTX drug-eluting stent back into the agency's better graces. This week, the company heralded results from a four-year trial that showed, despite its delivery system failures in the past, the paclitaxel-eluting device was more effective at preventing restenosis than a bare metal stent.
The four-year, 479-patient study at sites across the U.S., Europe and Japan investigated Zilver PTX's use as a treatment for peripheral artery disease in the superficial femoral artery, according to the company. The device showed 75% primary patency--effectively opening the artery--over four years compared with about 58% from a provisional bare metal stent. Additionally, 83.2% of Zilver PTX patients did not require revascularization after four years, as opposed to 69.4% with other treatments.
When it won FDA approval in November last year, Zilver PTX was the first drug-eluting stent cleared to treat peripheral artery disease. But just several months later, Cook was defending the device, which in rare cases had been found to separate from the delivery catheter used to place it in the artery.
Bloomington, IN-based Cook hopes to bolster confidence in Zilver PTX after the FDA issued a Class I--the most serious--recall of the device for reported delivery-system failures resulting in two adverse events, one of which involved a patient's death. Although the company did not acknowledge there was enough evidence to confirm that the delivery failure led to the adverse events, it did claim to have identified the flaw with the delivery system at the time.
"The four-year freedom from [target lesion revascularization] data documents the sustained clinical benefit of Zilver PTX," said data presenter Michael Dake, a cardiothoracic surgery professor at Stanford University Medical School, who acted as Cook's paid consultant. "When compared to standard of care therapy, consisting of either acutely successful [percutaneous transluminal angioplasty] or provisional bare stent placement after sub-optimal PTA, the paclitaxel-eluting Zilver stent provides a 45% reduction in the reintervention rate in this study."
"With these new data showing lasting patency at four years," said Cook VP Rob Lyles, "we're confident our Zilver PTX stent offers PAD patients a lasting solution."
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