www.fdanews.com/articles/182914-laminate-gets-ide-approval-for-study-of-vasq-device
Laminate Gets IDE Approval for Study of VasQ Device
August 4, 2017
The FDA awarded an Investigational Device Exemption to Laminate Medical Technologies to evaluate its VasQ device’s safety and efficacy.
The VasQ is an implanted blood vessel external support for patients needing arteriovenous fistula. Laminate’s clinical trial will enroll 129 male and female patients from 18 to 80 years old and track their progress over two years.
The device is already CE Marked and used in European and Israeli hospitals.