Tag: catheter

BioCardia gets FDA clearance for catheter to guide Helix delivery system

BioCardia has received US Food and Drug Administration (FDA) 510(k) clearance for its Morph DNA deflectable guide catheter, used to guide the Helix biotherapeutic...

Avance steerable introducer given FDA 510(k) clearance

The AVANCE steerable introducer product family (BioCardia) has received US Food and Drug Administration (FDA) 510(k) clearance. The AVANCE device is designed to introduce...

CRT 2019: Renal denervation using alcohol “seems very effective”

 The renal denervation bubble collapsed due to a single trial—SYMPLICITY HTN-3, but this trial’s findings went against the grain, Horst Sievert (Frankfurt, Germany) tells...
Spectranetics' Bridge

FDA issues class I recall for Spectranetics’ Bridge occlusion balloon catheter

Spectranetics has recalled the Bridge occlusion catheter “due to the possibility of a blocked guidewire lumen in some device units”. Using affected catheters could...