AMEND Trans-Septal System
Phase 1- Indications
- Mitral regurgitation
Company intelligence / Profile preview
Valcare Medical’s AMEND™ Trans-Septal System has demonstrated positive clinical efficacy out to 6 months in a first-in-human study of 17 patients. The company is enrolling patients in an EU pilot study and has received FDA approval to initiate an Early Feasibility Study in the US. The product is investigational only and not yet commercially available[5][6][8].
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