Pq Bypass Inc., of Milpitas, Calif., said that the Centers for Medicare and Medicaid Services (CMS) has agreed to cover its TORUS 2 investigational device exemption (IDE) clinical trial, which is evaluating the Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
The recent controversy over the use of paclitaxel in the peripheral vasculature has clouded the larger debate over whether bypass is superior to endovascular therapies for the lower limbs. However, a new study suggests that nitinol stents provide a feasible alternative to bypass even for lesions of the femoropopliteal artery that are 30 cm in length.
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.
The U.S. FDA has given Pq Bypass Inc. the greenlight to conduct a pivotal trial aimed at assessing its Torus stent graft in the treatment of peripheral artery disease (PAD) in the superficial femoral artery. The TORUS-2 study is the Milpitas, Calif.-based startup's second IDE approval in less than two years and the first pivotal IDE for an SFA stent graft since W.L. Gore & Associates Inc.'s Viabahn device, which notched an initial PMA approval in 2005.
Santa Clara, Calif.-based Shockwave Medical Inc. is working to build its business around the use of intravascular lithotripsy (IVL) in multiple arterial indications. Lithotripsy has been used to destroy kidney stones for decades, but now Shockwave's system is applying that technology to indications including coronary artery disease (CAD), above-the-knee peripheral artery disease (PAD) and below-the-knee PAD that each require a specific catheter.