Market Access Strategy for Medical Devices in Europe
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Rapid HTAs of four medical devices released in Tuscany
The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 8844 of March 02, 2023, Tuscany Regional Healthcare has published assessments of four medical devices in the cardiovascular and neurovascular treatment areas.
Below are the technologies that have been assessed:
- Intra-aortic occlusion device IntraClude by EDWARDS for patients undergoing endoscopic minimally invasive cardiac surgery with cardiopulmonary bypass;
- TactiFlex Ablation Catheter Sensor Enabled by Abbott for patients suffering from complex cardiac arrhythmias;
- Cerebral embolic protection device TriGUARD 3 by Keystone Heart for patients undergoing cardiac catheterization procedures to reduce the risk of cerebral embolism;
- Geometric thrombectomy system for the extraction of tough clots CERENOVUS NIMBUS by NEURAVI for patients with acute ischemic stroke due to neurovascular occlusion of large vessels and associated with resistance to mechanical thrombectomy.
See the regional decree and all assessments in Italian here.
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