Cardiovascular devices

In mid-August 2021, the Finnish Coordinating Center for Health Technology Assessment announced the release of the four accomplished rapid hospital assessments (HTA) performed by the Helsinki University Hospital. The accomplished rapid HTAs concern the cardiovascular, peripheral vascular, and endoscopy technology groups.

In July 2021, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (inducing and maintaining normothermia using temperature modulation devices to improve outcomes after stroke or subarachnoid hemorrhage) and four new Medtech Innovation Briefings (HealthVCF for detecting vertebral compression fractures on CT scans, trublood-prostate for triaging and diagnosing people with prostate cancer symptoms, AI technologies for detecting diabetic retinopathy, and Acumen IQ sensor for predicting hypotension risk).

On July 30, 2021, the Swiss Federal Statistics Office (UFS) published the 2022 version of the procedure code (CHOP) nomenclature in the German language. The newly introduced codes concern various technology groups, such as cardiovascular, gastrointestinal, neurology, interventional radiology, orthopedics, gynecology, and others.

In July 2021, the Austrian Institute for Health Technology Assessment (AIHTA) published six new decision support documents and one update to a previous decision support document. The assessed topics included percutaneous left ventricular assist devices, liposuction for surgical therapy of lipoedema, triphasic biomaterial for augmentation of the osteoporotic femoral neck, endoscopic plication therapy in patients with gastroesophageal reflux disease (GERD), allogenic bone screw Shark Screw® in patients with hallux valgus or scaphoid fractures/pseudarthroses, and surgical interventions for the treatment of benign prostatic hyperplasia. The updated decision support document concerned implantable bulking agents for fecal incontinence.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in June 2021. Recommendations concern cardiovascular and peripheral vascular devices, orthopedic devices, liquid for embolization, and medical aids.

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.

In mid-June 2021, the document "Changes and innovations in the 2022 LKF model" (Änderungen und Neuerungen in den LKF-Modellen 2022) was published. The document summarizes the most significant changes and innovations in the LKF model for inpatient and outpatient care. The newly added procedure codes concern mainly the cardiovascular, e-Health, and gastrointestinal area.

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

The Health Sciences Institute in Aragon (IACS) systematically evaluates healthcare technologies and facilitates the promotion of research, effective innovation, and decision-making in health services through knowledge management. Currently, the IACS is working on assessments of efficacy, effectiveness, and safety of intraoperative radiation therapy in breast cancer, determination of preeclampsia biomarkers SFlt-1 and PlGF, treatment of congenital ventricular septal defect by cardiac catheterization, and others.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May 2021. Recommendations concern orthopedic devices, cardiovascular, peripheral vascular, and neurovascular devices, medical aids, and pulmonary artery pressure sensor.

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

On May 6, 2021, the Federal Joint Committee (G-BA) announced the start of consultations about the design of three co-funded studies for cardiovascular methods in accordance with §137e SGB V.