Over 7 million catheterization procedures are performed worldwide each year, with a 10-20% complication rate in closing the vascular access site. The routine administration of anticoagulant medication can further delay sealing the vessel. Manual compression has been the standard of care for closure after percutaneous coronary interventions, but it requires 4-12 hours of bed rest, significant medical staff time, and associated higher costs. Recently, several closure devices have been introduced, but complication rates are still high and immediate ambulation is still not recommended. Rocky Mountain Biosystems, Inc., proposes developing a new technology (VeniSeal) to address the vascular closure problem. VeniSeal which uses a proprietary sealing compound that is activated using inductive coupling to achieve immediate and secure closure of both the sheath tract and vessel puncture. The sealing process can be done in the presence of blood and excess hemostatic pressure. In Phase I, we will build a prototype VeniSeal activation device, coil, and improve the adhesive compound. The device and adhesive will be used to seal vascular openings in ex vivo laboratory tests to evaluate the potential of this method to seal wounds in humans. In Phase II, a simple applicator will be designed and tested in animals.
Flock, Stephen T; Marchitto, Kevin S (2005) Progress towards seamless tissue fusion for wound closure. Otolaryngol Clin North Am 38:295-305 |