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By law NIS need to be registered. The research question underlying this systematic analysis was primarily to learn about the scientific objectives of these. On the cutoff date (Aug. 7th, 2015) information available through the public database was systematically evaluated. It comprised 251 NIS on 581 pharmaceuticals with a total planned patient enrollment of 406,831. Of 33 final reports available only 8 conformed to the formal requirements. For at least 14 (and possibly up to 31) additional NIS such reports should already have been posted online. The most common research questions a NIS addressed were effectiveness in practice (efficacy) and drug safety. The addressed pharmaceuticals were mostly patented me-too drugs and generic drugs/biosimilars. In 31 of the 33 reports the respective research questions were answered with a positive result for the NIS. Due to deficits in reporting requirements for the public database and due to modest reporting morale and accountability the informed public is in no position to make well-founded statements on completed and ongoing NIS.

Robot-assisted surgery is already performed in many disciplines, especially in urology and gynaecology.
The report assessed the efficacy and safety of robot-assisted surgery, compared to laparoscopic and open surgery for partial nephrectomy, adrenalectomy, radical prostatectomy, radical cystectomy, hysterectomy and ovariectomy.
Furthermore, the costs (acquisition, maintenance, instruments) of robot-assisted surgery from the perspective of hospitals were calculated and the future of robotic surgery was evaluated.

Mitral valve regurgitation (MR) or mitral insufficiency is a common disease esp. among the elderly. MR may be acute or chronic, depending on the underlying pathology: accordingly, it must be distinguished between primary (degenerative) MR (DMR) and secondary (functional) MR (FMR). Since recent years new minimally invasive procedures are available for inoperable or high-risk patients. This assessment examines the question of efficacy and safety of mitral valve repair using minimally invasive procedures such Mitraclip® for inoperable patients with DMR or FMR; Carillon® inoperable patients with FMR; NeoChord DS 1000 for operable patients with DMR to answer.

Two of the evaluated medical devices, NeoChord DS1000 and CARILLON® are still at an early stage of development. The MitraClip® however, was already implanted worldwide in around 23,000 patients before results of a comparative study has been published.

Balloon Eustachian Tuboplasty (BET) is a minimally invasive treatment option for patients with chronic tube dysfunction which involves passing a balloon catheter into the Eustachian tube. Currently, there are 2 CE marked products on the market for BET: the Bielefelder Ballonkatheter/TubaVent® produced by Spiggle & Theis  and the AERA^TM produced by Acclarent Inc./Johnson & Johnson.

This report, which is based on a EUnetHTA assessment published in February 2015, aims to compare the effectiveness and safety of BET in patients aged >12 years with tympanostomy and medication.