Edwards Lifesciences (Irvine, CA) may win a German ban on sales of heart valves by Medtronic (Minneapolis, MN), according to analysts at Canaccord Genuity. In a report, analysts Jeffrey Chu and Jason Mills predict that there is a 60% probability that a lawsuit by Edwards Lifesciences against Medtronic will end in a sales injunction against Medtronic’s CoreValve transcatheter aortic valve replacement device.
According to analysts, the lawsuit against Medtronic first entered the German District Court of Mannheim in 2012. Earlier this spring, Edwards also entered a motion in the United States District Court to permanently ban Medtronic from selling its CoreValve system in the U.S. market. A trial date is still pending for this motion.
Germany is the largest European market for transcatheter aortic valve implantation. If the German legal decision goes in Edwards’ favor, this will be a huge win for the company’s Sapien valve and a significant loss for Medtronic. In November of last year, the Federal Circuit and the United States Court of Appeals ruled in favor of Edwards, supporting a lower-court jury verdict in 2010 that determined that CoreValve violated Edwards’ TAVR patient. This winter, Medtronic was forced to pay $83.6 million as part of this patent infringement settlement.
At that time, Medtronic stated that it would continue clinical studies of its CoreValve system. The company also announced that it would continue to sell the CoreValve system in Europe. For now, Medtronic’s CoreValve doesn’t have approval in the United States. If the courts rule in favor of Edwards, the company may never get that chance.
- How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance - Webcast
- 3 Tips for Successfully Launching an Outsourced Medical Device - Webcast
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast
- Rapid Prototyping for Medical Devices - Webcast
- New Approaches to Assessing Biocompatibility for Medical Devices - Webcast
- Five Mistakes That Can Derail Your Product Development Effort - Webcast