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 6700 of March 27, 2024, Tuscany Regional Healthcare published three new assessments and one re-assessment of medical devices in the cardiovascular, men’s health, nephrology and urology, and surgical procedures areas.

The assessed technologies are provided below:

• Tricuspid valve reconstruction system Cardioband tricuspid system by Edwards Lifesciences for patients with severe tricuspid valve insufficiency caused by annular dilatation who remain symptomatic on medical therapy and are at high risk for surgery (update);
• Prostatic urethral lifting system UroLift by Neotract for young patients suffering from benign prostatic hyperplasia (BPH) and retrograde ejaculation who need to preserve fertility;
• Urethral drug coated (paclitaxel) balloon catheter OPTILUME by Urotronic for patients with recurrent urethral stricture resistant to surgical urethrotomy treatment candidates for urethroplasty treatment;
• Sterile silicone breast prostheses Motiva Implants Ergonomix Round SmoothSilk/SilkSurface by Establishment Labs for female patients requiring breast reconstruction, patients - candidates for unilateral mastectomy with particular conformation of the breasts (medium-large volume, medium-high ptosis), female patients aged > 18 years requiring breast augmentation.

See the regional decree and all assessments in Italian here.

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