Intact Vascular’s Tack Peripheral Dissection Repair Device Earns PMA
The approval of the Intact's peripheral artery dissection repair device is based on results from the 213-patient TOBA II trial, which showed Tack resolved 92.1% of dissections in peripheral arteries following balloon angioplasty.
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A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Qiagen's therascreen FGFR RGQ RT-PCR companion diagnostic for Janssen's new drug to treat specific types of urothelial cancer and Intact Vascular's Tack device to treat dissections of the above-the-knee peripheral arteries following angioplasty.
Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.
Three-month results of the SPYRAL HTN-OFF MED pivotal trial show renal denervation with Medtronic’s Symplicity Spyral system significantly reduced blood pressure in hypertensive patients not taking anti-hypertensive medications.