Showing posts with label Vascuseal. Show all posts
Showing posts with label Vascuseal. Show all posts

Wednesday, June 11, 2008

Vascular Closure - Hemostasis of the femoral artery


Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis. Simple compression – the use of hand pressure, clamps, and/or sandbags – is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patient’s clotting capability to return to a normal state.Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort. Once hemostasis has been achieved, the patient’s leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding.

Vascular Closure Products
St.Jude - Angioseal
Medtronic Inc. - EVS vascular stapling system, Clo-Sur PAD
Covidien - VascuSeal
Abbott - Closure S, Perclose A-T, Perclose ProGlide, Prostar, StarClose, Chitoseal
Cardiva - Boomerang
Medafor - MPatch
Sutura - SuperStitch
Vascular Solutions - Duett, Duett Pro, D-Stat
Radi Medical - FemoStop, RadiStop

Thursday, May 1, 2008

Covidien Introduces the VascuSeal


Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the VascuSeal™ Vascular Sealant System throughout Europe and in select Middle East markets. VascuSeal™ offers surgeons a unique advanced hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period. VascuSeal™, which is CE-Marked, is intended for use as a surgical sealant during arterial and venous reconstructions to seal suture lines.
Unlike a hemostatic agent, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully. The VascuSeal™ Sealant System offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding.
The VascuSeal™ sealant technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. VascuSeal™ sealant polymerizes within seconds when sprayed on the suture line and is blue in color which provides the vascular surgeon visualization of coverage and thickness of the material upon application. Postoperatively, VascuSeal™ sealant continues to seal the suture line as healing progresses under the gel. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.
“The VascuSeal™ Vascular Sealant System represents another innovative product in the BioSurgery marketplace,” said Scott Flora, President, Surgical Devices, Covidien. “We expect VascuSeal™ to be well-received by surgeons looking to improve patient outcomes, save time and reduce blood loss during surgical procedures,” added Flora.