All VCDs have demonstrated rapid hemostasis and a decreased time to ambulation when compared to manual compression(1-4). Vasoseal™ has been associated with the highest risk of infection, while Angiolink™ and Starclose™ are felt to have the lowest risk (1-4). Angioseal™ theoretically has a higher risk of thromboembolic events due to the intravascular collagen anchor. The suture-mediated devices utilize primary healing (end to end anastomosis at the arteriotomy site), but are the most complex technically and have the highest rate of device and operator failure. Collagen and ProcoagulantsThe Vasoseal™ closure device (Datascope Corp., Montvale, NJ) was introduced in 1995 (revised in 1999and 2002) and utilizes an extravascular Type-1 collagen produced from bovine tendons. When deployed at the arteriotomy site the collagen initiates coagulation by activating platelets (secondary healing). Vasoseal™ isFDA approved for both diagnostic and interventional procedures, with a single device used for 5-8 French sheath sizes. The Angio-Seal™ device (St. Jude Medical, St. Paul, MN) achieves hemostasis by sandwiching the puncture site between an intravascular bio-absorbable (over 8-12 weeks) anchor and an extravascular bovine.......................Read more HERE (its a verified safe download from Adrive)
For Current US Vascular Closure Trials go HERE
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.
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
Morris Innovative - FISH
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
AccessClosure - Mynx
Cardiva - Boomerang
Medafor - MPatch
Sutura - SuperStitch
Vascular Solutions - Duett, Duett Pro, D-Stat
Radi Medical - FemoStop, RadiStop
Vascular Closure
Lets take a look at the vascular closure hemostat range starting with a look at the market with Kensey Nash. There is a full presentation available HERE but key slides featured below.
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