ARTICLE SUMMARY:
In this week’s roundup: The EU’s Circulatory System MDR expert panel expressed serious concerns with a notified body’s recent clinical assessment of what would be Europe’s first transcatheter tricuspid replacement system; China drafted guidance on remote monitoring devices and lubricated vascular devices; an indefinite delay of CMS’ embattled radiation oncology bundled payment model is imminent; and more news from FDA and MDIC.
Top Pick: EU Panel Strikes Again
Tricuspid device needs RCT, expert panel says:
The EU Circulatory System expert panel delivered perhaps its most severe feedback yet to a notified body’s assessment of a heart device in an opinion posted August 24. The NB, Netherlands-based Dekra Certification in this case, should have asked the manufacturer of what would be the first (unnamed) transcatheter tricuspid valve replacement system in Europe to conduct a randomized controlled trial comparing the device to optimal medical therapy, the heavily-redacted opinion, which was actually completed in June, stated. The single-arm study results signed off on by Dekra to support a CE mark doesn’t cut it, the panel argued. “Overall, the panel disagrees with the conclusions of the NB and considers the clinical evidence provided by the manufacturer is not sufficient to ensure the demonstration of a positive benefit-risk ratio for the intended medical purpose of this device,” the opinion said.
This is the third Clinical Evaluation Consultation Procedure (CECP) opinion delivered by the circ panel since the MDR was established. All of them have reviewed Dekra assessments of heart valve replacements (pulmonary and aortic in the prior instances) and each have questioned some core components of the NB’s positive decisions for the devices in questions. Under the EU MDR, high-risk devices that meet certain thresholds for novelty and risk are subject not only to a notified body conformity assessment, but also an independent review of the NB’s clinical assessment by a relevant EU expert panel. The panel opinion is not technically binding, but the NB must provide a rationale if it doesn’t follow the recommendations. So it is expected that in this tricuspid case and others, companies will be hit with additional questions and data demands from NBs based on the panel reviews. In addition to the circ panel, there have been two other MDR expert panel opinions—one in orthopedics and one for a dental device—that have also subjected devices to serious extra scrutiny. (See “Inaugural Expert Panel Opinion Underscores EU MDR Evidence Demands,” Market Pathways, July 26, 2021.)
The European Commission redacts the company and product names in the CECP opinions. In this case, the two investigational devices that are the most likely candidates for this latest opinion are Medtronic plc’s Intrepid and Edward Lifesciences Corp.’s Evoque, both novel tricuspid valve replacement systems under clinical development.
