Rapid HTAs of nine 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 13989 of June 29, 2023, Tuscany Regional Healthcare has published assessments of nine medical devices in the cardiovascular, peripheral vascular, diagnostic imaging areas, and surgical procedures.

Some examples of the assessed technologies are provided below:

• Impella CP with SmartAssist, intracardiac pump for the left ventricular support by Abiomed for patients with cardiogenic shock, with rapidly deteriorating heart failure, and patients with high-risk percutaneous interventions that require mechanical assistance greater than that provided by the intra-aortic balloon pump (IABP) and extracorporeal membrane oxygenation (ECMO) or have contraindications to the placement of the IABP (thoracic aortic aneurysm abdominal pain, severe aortic vascular insufficiency);
• Venus P-valve, transcatheter pulmonary valve replacement systems by Venus-Medtech for patients affected by congenital pathologies (e.g., Tetralogy of Fallot), undergoing previous enlargement of the right ventricular outflow tract by patch, requiring pulmonary valve replacement;
• B-Lite Microthane and B-Lite POLYtxt coated silicone gel breast implants by G&G Biotechnology for patients with breast cancer undergoing mastectomy and prosthesis reconstruction.

Also, other technologies from the cardiovascular and peripheral vascular areas were assessed.

See the regional decree and all assessments in Italian here.

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