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Acellular tissue-engineered vessel granted FDA Regenerative Medicine Advanced Therapy designation for advanced PAD
Humacyte recently announced it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its investigational acellular tissue-engineered vessel (ATEV), designed to treat patients with advanced peripheral arterial disease (PAD). This RMAT…
WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study completes enrolment
Merit Medical has announced that it has completed enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomized, controlled, multicenter study comparing the Merit WRAPSODY cell-impermeable endoprosthesis (CIE) to percutaneous transluminal angioplasty (PTA)…