The U.S. FDA has been easing gently down the road of real-world evidence (RWE) in regulatory decision-making, and the case of the Watchman left atrial appendage device is instructive in this regard. Robert Shipley, of Boston Scientific Corp. (BSX), said on webinar hosted by the Advanced Medical Technology Association that the FDA changed gears and agreed to a registry for a post-approval study for the first generation Watchman, but added that the use of registry data and other RWE for approval of a next-generation device is as yet more aspirational than practicable.

Avinger Inc. has received U.S. FDA clearance for a its Ocelaris next-generation, image-guided chronic total occlusion (CTO) crossing system for patients with peripheral artery disease (PAD). The catheter-based system, which will be sold under the brand name Tigereye, provides real-time imaging from within the vessel during a CTO-crossing procedure. It will be available on a limited basis beginning later this year.

New medical instruments with integrated soft electronics could improve diagnosis and treatment of cardiac conditions. The surgical tools use soft materials that conform to the body’s tissue and permit a single catheter to combine diagnostic and therapeutic functions while providing real-time feedback and electrophysiological information.

HONG KONG – Singapore-based Genesis Medtech International Pte. Ltd. has acquired the Chocolate Touch drug-coated balloon angioplasty asset from Pleasanton, Calif.-based Trireme Medical LLC. The drug-device technology asset in question is designed with the intention of providing a safer and more effective treatment for patients suffering from peripheral vascular disease, compared to traditional balloon angioplasty.

Pq Bypass Inc. received breakthrough device designation from the FDA for its Detour system, the first to permit fully percutaneous femoropopliteal bypass to treat extremely long, complex blockages in the superficial femoral artery (SFA). “This designation is a major milestone for Pq Bypass, and we expect this technology to change the paradigm for complex SFA treatment in the way EVAR and TAVR changed the paradigm for aortic repair,” said Rich Ferrari, chairman and CEO of Pq Bypass.

The U.S. Centers for Medicare and Medicaid Services (CMS) finalized its Medicare inpatient payment rule for fiscal 2021, and Boston Scientific Corp., of Marlborough, Mass., was perhaps a surprise winner with a new technology add-on payment (NTAP) for its Eluvia paclitaxel-coated stent for the lower limbs. The Eluvia had faltered at a previous NTAP application due to the controversy over paclitaxel in devices for the peripheral vasculature, but Boston Scientific said in a Sept. 3 press release that the decision to grant an NTAP payment “is particularly important,” given the scrutiny applied to paclitaxel’s use in these devices.

Cryoablation for paroxysmal atrial fibrillation (PAF) is not the standard of care, but a recent study may change at least some clinicians’ thinking on that score.