- Cardiva Medical has received FDA premarket approval of its Vascade MVP vascular closure system for use in electrophysiology procedures, the company announced Tuesday.
- The device can be used in procedures such as cardiac ablation and left atrial appendage closure, potentially benefiting more than 400,000 patients a year, the vascular products maker said.
- The company said the Vascade device is the first vascular closure system designed and labeled for multi-site venous closure for 6-12 French inner diameter sheaths.
Vascular closure devices were first introduced in the 1990s with the aim of speeding wound healing, also called hemostasis. The devices offer an alternative to manual compression, which is still considered the gold standard for stopping the flow of blood from access sites to perform medical procedures. Abbott Vascular, through its purchase of St. Jude Medical, is one of the biggest makers of the devices, offering a suite of vascular closure products, including its Angio-Seal line.
The Cardiva device places a collagen patch on the outside of each vessel puncture site that is absorbed into the body within a short time, leaving no permanent components behind, the company said. A small mesh disc is placed against the inside of the vessel wall to temporarily stop the bleeding, releasing a collagen patch into the tissue.
The disc is then removed. The collagen patch expands, creating a seal to stop the bleeding. Further access to the vessel is possible if additional procedures are required, the company said.
FDA approval of the device was based on Cardiva's pivotal trial of 204 patients who underwent arrhythmia ablation procedures. In the study, patients treated with the Vascade MVP system were able to walk significantly sooner than those who underwent manual compression, and 58% fewer patients used opioid medication after their procedure.
Compared to manual compression, the Vascade MVP system met all primary and key secondary endpoints in the study, including reduced time to ambulation, total post-procedure time, time to discharge eligibility and reduced use of opioid pain medication, Cardiva said. The results were presented in November at the annual meeting of the American Heart Association.
Vascade MVP is indicated for percutaneous closure of femoral venous access sites in patients who have undergone catheter-based procedures utilizing 6-12F inner diameter procedural sheaths, with single- or multiple-access sites in one or both limbs.