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.

Transit Scientific LLC’s XO Cross Microcatheter platform was used in its first cases worldwide last week following its May 2020 clearance by the U.S. FDA and showed improved control and imaging. The company designed the platform to facilitate guidewire support, guidewire exchange, and contrast media injection during complex peripheral vascular interventions such as late-stage peripheral artery disease (PAD) and critical limb ischemia (CLI).

In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.

Boston Scientific Corp. has received the U.S. FDA’s nod for a high bleeding risk (HBR) indication for the Synergy drug-eluting stent system.