Medical Devices in the Region of Tuscany, Italy: Definitions of Innovative Devices and Potentially Innovative Devices and Their Impact on Procurement Decisions.

In the region of Tuscany in Italy, since 2019, medical devices belonging to risk classes 2b, 3, or active implantable have been managed by a multidisciplinary health-technology assessment body initially composed of eight members and extended to 23 members in 2022, thus creating the Centro Operativo. In 2021, an original algorithm for the identification of innovative devices based on objective criteria was developed and formally recognized over the following years. However, since these criteria identified only a small number of innovative devices, we tried to develop another algorithm aimed at identifying a new classification (called "potentially innovative device"), which was intended to be intermediate between full innovation and no innovation.

Efficacy and Safety of Cardioband in Patients with Tricuspid Regurgitation: Systematic Review and Meta-Analysis of Single-Arm Trials and Observational Studies.

: The incidence and prevalence of tricuspid regurgitation (TR) are increasing worldwide. "Traditional" drug therapy with diuretics is often ineffective and the identification of new strategies, including non-pharmacological ones, is an urgent need. The aim of this study was to summarize the results on the efficacy and safety of Cardioband, one of the few approved transcatheter tricuspid valve repair systems, in patients with TR.

Treatment of Patients With De Novo Small-Vessel Coronary Lesions: Analysis of Six Randomised Controlled Trials Comparing Paclitaxel-Coated Balloons With Drug-Eluting Stents.

Both paclitaxel-coated balloons (PCB) and drug-eluting stents (DES) are indicated for the treatment of de novo small-vessel coronary lesions. Since the evidence comparing these two types of devices is limited, we undertook a meta-analysis on this issue. Our meta-analysis compared the efficacy of PCB vs.

Real-world data on the effectiveness of TYRX and TauroPace for preventing CIED infections.

Background: The implantation of cardiac implantable electronic devices (CIEDs) carries a known risk of infection. Two devices (TYRX and TauroPace) have been proposed to reduce this risk.

Methods: The aim of our study was to compare the effectiveness of TauroPace and TYRX.

Studying the Outcomes in Patients with Tricuspid Regurgitation Treated with Valve Repair or Valve Replacement: Interpreting the Survival Pattern on The Long Term by Application of Artificial Intelligence Methods.

Background: The reconstruction of individual patient data from published Kaplan-Meier survival curves is a new technique (often denoted as the IPDfromKM method) for studying efficacy in cases where multiple trials are available, and the endpoint is long-term mortality. In patients with tricuspid regurgitation, both valve repair and valve replacement have been proposed to improve prognosis; 6 controlled clinical trials (CTs) have been conducted to compare the two therapeutic options mentioned above. The objective of our analysis was to study these six trials through the application of the IPDfromKM method.