MagicTouch Balloon Trial Shows Non-Inferiority to Stents in Coronary Disease
- Reports
- 3
- Developments
- 1
- Repetition
- 67%
New informationRepeats or wire copies
What happened
The TRANSFORM II randomized trial found that the MagicTouch Sirolimus Coated Balloon was non-inferior to contemporary everolimus-eluting stents for Target Lesion Failure at 12 months in patients with de novo coronary artery disease. The trial, which enrolled 1,842 patients, has expanded its enrollment to South America and Europe.
From prnewswire.com
Why it matters
The positive clinical results confirm that the MagicTouch SCB matches contemporary best-in-class stents. This clinical data could support faster regulatory review and market access for the device in various regions.
From prnewswire.com
Who's involved
- South AmericaA region where the trial is expanding enrollment, signaling increased market demand for the device.
- EuropeA region where the trial is expanding enrollment, signaling increased market demand for the device.
- AsiaA region where trial enrollment signals increased market demand for the device.
- European CommissionThe regulatory body whose review process could be supported by the positive clinical data.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- South AmericaSpeculative
Might see increased market demand for the device, potentially affecting sales.
Keep exploring
The entities involved
-
South America
continent located mainly in the southwestern quadrant of the Earth
-
Europe
terrestrial continent located in north-western Eurasia