Clinical trials

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.

The goal of this observational pilot study is to learn about the ability of the PureWick® Flex Female External Catheter and the PureWIck® Male External Catheter to capture urine output in adult ICU patients compared to indwelling urinary catheters. The study will also gather feedback from ICU clinicians about the suitability of PureWick® urine output data to inform clinical decision-making.

Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.

Post-market, observational study to assess effectiveness of TissuePatch SF in managing/preventing air leaks after lung resection.

This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .

The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.