BD (NYSE: BDX) recently announced that it has begun enrollment for its post-market surveillance study of its WavelinQ arteriovenous endovascular fistula device.
The Connect-AV trial is a prospective, single-arm, open-label study that will follow WavelinQ EndoAVF system patients for 24 months. Its dual primary effectiveness endpoints are the percentage of subjects dialyzing with successful 2-needle cannulation for at least 75% of dialysis sessions over a 28-day period, and subjects who are maintaining primary patency at six months. The primary safety endpoint is freedom from the device and procedure-related serious adverse events for 30 days.
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