Medtronic announces CE mark and European launch of the Euphora semicompliant coronary balloon catheter

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Medtronic plc has launched the Euphora semicompliant balloon dilatation catheter in countries that recognise the CE mark. The first patient case with the Euphora was recently performed by Richard Edwards, consultant cardiologist at the Freeman Hospital in Newcastle, UK. The device is not available in the USA.

“After performing the first patient case with Euphora, it is the most deliverable balloon catheter I have used,” said Edwards. “The exceptionally low crossing profile and pushability make it ideal for complex situations and workhorse lesions alike.”

Pre-dilatation with a semicompliant balloon helps physicians determine lesion characteristics, stent selection and facilitates stent access to the lesions—a crucial step for patients with complex lesions.

Medtronic says that the balloon catheter features several design advancements including:

  • Delivery system with PowerTrac technology to provide improved deliverability through tight lesions. The delivery system was first introduced with the Medtronic NC Euphora noncompliant balloon dilatation catheter in 2014 and is also featured with the Medtronic Resolute Onyx drug-eluting stent. ­­­
  • Ultra-slim balloon material, a tapered proprietary inner shaft design and an optimised mini-wrap to reduce the wall thickness of the balloon and contribute to the extremely low crossing profile.
  • Improved insertion and retraction force to enhance navigation to lesion sites when using the “kissing balloon” technique for treating bifurcated lesions.
  • Environmentally-friendly packaging, a reduced box size that has a smaller footprint on congested shelves and improved product labelling for fast readability to improve efficiency in the cath lab.
  • Enhanced crossability may create economic value to the cath labs through the use of a single balloon prepping a lesion, thus reducing the need for the “step up” technique which requires several balloons of different size to first cross the tight lesions and then gradually expand sizing before treating with a stent.

The Euphora semicompliant balloon is the latest in a series of 12 new product introductions planned over the next two years.