Centers for Medicare & Medicaid Services finalized its decision to cover only in FDA-approved studies. But the agency noted that could include prospective longitudinal studies for on-label use of a device covered by a post-approval study.
Investigators mapped U.S. zones where it would make better sense to get early thrombolysis at the closest primary stroke center before transportation to a endovascular-capable hospital ("Drip 'n Ship") versus direct transport to the comprehensive stroke center "mothership" in a modeling study published in Stroke.
The polymer-free, drug-eluting stent received Europe's CE Mark, device maker Alvimedica announced. The device elutes a novel combination of sirolimus and a fatty acid dubbed "Amphilimus" and will undergo investigation in the Diab8 trial.
Medtronic's CoreValve Evolut R was granted CE Mark as well for the , the largest transcatheter aortic valve replacement device available in Europe. This follows the of the valve in October 2016. (Mass Device)
Ablation for was associated with a modest success rate of 73.6% in Europe. At 12 months, almost half of patients were still on antiarrhythmic drugs and one-tenth experienced complications, according to the registry study published in European Heart Journal.
Stent graft-related complications from may stem from increased pulsatile wall stress in segments adjacent to the device, researchers suggested in the Journal of Endovascular Therapy. The finding appears to help explain retrograde dissection, aneurysm formation, and rupture.
Most patients with critical limb ischemia and infrapopliteal artery blockages improved with a to the foot using an everolimus-eluting stent. (Vascular and Endovascular Surgery)
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