M&L Healthcare's First MedTech Investment Receives FDA Approval Following Successful US Trials
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월요일, 9월 18, 2023
Chin Na, Amputation, The New England Journal of Medicine, M&L, CE marking, Type 2 diabetes, Catheter, Johannes Hoffmann (vascular surgeon), Vein, Statistics, COVID-19, Clinical trial, Foot, Quality of life, St Luke's Hospital, Singapore, Leg, Artery, Changi General Hospital, Elective surgery, PMA, Transcatheter arterial chemoembolization, Patient, Investment, MD, Series, Engineering, Mortality, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medtech, Food, Wound healing, Pharmaceutical industry, Medical device, Valvulotome, EU, CLTI
The approval comes after successful outcomes in the PROMISE II Pivotal trial in the United States, recently published in the New England Journal of Medicine.
Key Points:
- The approval comes after successful outcomes in the PROMISE II Pivotal trial in the United States, recently published in the New England Journal of Medicine.
- It is the first and only FDA-approved device for TADV and provides no-option CLTI patients with access to a minimally invasive treatment.
- Type 2 diabetes is a major cause of CLTI, a condition that affects millions of people globally.
- The United States alone witnesses approximately 150,000 ischemic amputations each year, resulting in healthcare costs of over US$95 billion.