Adjunctive technique for the use of proglide vascular closure device. Proglider rotary glide path files regardless of the paths complexity, proglider is. Complete removal of the impella sheath can now occur, and the action of cinching and locking the deployed perclose proglide sutures rounds out the preclose technique. The perclose proglide smc system is depicted in figure 2. In the cases with prostar we used one device and in cases with perclose proglide, two devices. The perclose proglide smc system is used without or, if requir ed, with adjunctive manual compression. The removal of arterial cannulas using a perclose device abbott. How supplied the perclose proglide smc device and accessories are provided sterile and nonpyrogenic in unopened, undamaged packages. Comparison of complication and success rates of proglide. During closure of arteriotomy sites using a 58 f procedural sheath, use manual. The primary objective of this study was to evaluate the safety and performance of proglide in the closure of the venous access site in subjects treated with a largecaliber femoral vein sheath 24f. Percutaneous removal using perclose proglide closure devices. Moreover, new players have introduced new and advanced suturebased devices, in 2016, for vascular sealing system vss products. Anz 080101 1211 collar needle plunger body marker port posterior side of device.
Perclose proglide suturemediated closure system provides the security of suture for vascular closure of 5f 21f femoral artery access sites. Seal p perclose proglide in preclosing 14fr to 20fr access sites for endurant endografting in the treatment of asymptomatic infrarenal aortic. The perclose is a stitch that is introduced through the femoral puncture site to close the femoral arteryvein and stop the bleeding. The perclose proglide smc system is used without or, if required, with adjunctive manual compression. We describe an adjunctive technique for the use of the proglide vascular closure device to improve hemostasis. For access sites in the common femoral artery using 5f to 21f sheaths. Comparative data of single versus double proglide vascular. Once the canal can be manually reproduced, a manual or dedicated mechanical glide path file may be used to expand the working width in preparation for shaping procedures. Closure devices are widely used in femoral access cardiovascular procedures for early ambulation and potential morbidity reduction. Pdf use of a perclose proglide device for percutaneous. Proglider is a singlefile, singleuse glide path file. The perclose proglide smc system is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5f to 21f sheaths.
For sheath size s greater than 8f, at least two devices an d the preclose technique are required. Perclose at, perclose, prostar xl, and perclose proglide by abbott vascular u. Product info our online product catalogs provide the very latest information available, right at your fingertips. Download catalogs by product family in pdf format, or view the entire abbott vascular inventory in excel. Heparin was reversed half dose and manual compression was. This perclose proglide smc device is composed of a plunger, handle, guide. Methods we retrospectively analyzed the prc after pevar for the treatment of aortic aneurysm or dissection in our center from december 2012 to november 20. Perclose definition of perclose by the free dictionary.
However, the precaution, preparation and procedure techniques have not been well described in the literature. Perclose proglide suturemediated closure system abbott. Schneider, md associate professor of surgery chief, vascular and endovascular surgery. There was no immediate arterial stenosis or hematoma. The perclose proglide smc system is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures. Purpose to investigate the predictors and treatment of the 6fr perclose proglide related complications prc in percutaneous endovascular aortic repair pevar.
The same simulator can be produced by downloading these stl files, while outsourcing of its manufacture is possible when physicians do. Patients presenting with cardiogenic shock or those who required an intra aortic balloon pump placement during the cardiac catheterization procedure were excluded from the study. Clinical outcome data on the use of suturemediated devices for large femoral arterial access in structural heart interventions is limited. Terumo, tokyo, japan through the arterial cannula, the ecmo arterial cannula was pulled back and removed by. Instead of open arteriotomy repair, successful percutaneous perclose proglide postclose technique has been reported for venoarterial extracorporeal membrane oxygenation vaecmo decannulation. Internet explorer is no longer supported by microsoft since the end of 2015. Vascular closure devices market growing at a cagr of 6. A one file glide path solution made with mwire niti alloy uniquely shaped with a variable taper conveniently packaged in presterilized blister packs 3 per pack all files are size 16. Fda summary of safety and effectiveness data page 5.
View the article pdf and any associated supplements and figures for a period of 48 hours. Possible mechanism for common femoral artery occlusion. Pdf femoral artery closure versus surgical cutdown for. Percutaneous removal using perclose proglide closure. Access site management with vascular closure devices for. For access sites in the common femoral vein us ing 5f to. Federal register perclose, inc premarket approval of. A smallsized hand file is initially used to scout, expand, and refine the internal walls of the canal. This perclose proglide smc device is composed of a plunger, handle, guide, and sheath. It looks like youre using an obsolete version of internet explorer.
This closure device uses a polyester pretied suture knot to close an arteriotomy site after cardiovascular procedures. For sheath sizes greater than 8f, at least two devices and the preclose technique are required. This closure device stops the femoral arteryvein from bleeding and allows earlier ambulation and discharge. The perclose proglide 6f smc system is designed for use in 5f to 21f access sites. Product barcodes enable direct scanning for easy reordering. Perclose proglide suturemediated closure system starclose. Currently approved vascular closure devices cardiac. Perclose synonyms, perclose pronunciation, perclose translation, english dictionary definition of perclose. For access sites in the common femoral vein using 5f to 24f sheaths. If you need help accessing information in different file formats. We assessed the efficacy of the perclose abbott vascular devices, santa clara, ca, usa suture. Abbotts perclose proglide vascular closure device, which offers percutaneous suturemediated closure, has the broadest indicationfor both femoral arterial and venous access sites. Perclose proglide vascular closure percutaneous repair.
After direct puncture in the proximal portion of the arterial cannula and placing a 0. A randomized trial comparing compression, perclose. Some of the investigators advocate the use of three proglide devices for sheaths larger than 22 f. We instruct the patient of normal care of the groin afterwards. Perclose closure device breakage and embolization during. The interventionalist can then deflate the balloon, using digital subtraction angiography through the wirelumen of the balloon to verify zero leakage at the largebore. A perclose proglide device was obtained for simulating closure of the vessel.
Material and methods patients underwent either percutaneous femoral artery closure pa group or surgical cutdown sc group for evar between july 2011 and june 2016 and evar procedures were used for all. Background to compare the outcome and complication rates of femoral artery closure and surgical cutdown for endovascular aortic repair procedures evar. The perclose proglide abbott vascular, santa clara, calif is indicated for the closure of 5f to 21f femoral artery. The perclose proglide abbott vascular, santa clara, calif is indicated for the closure of 5f to 21f femoral artery access sites. Angioseal and perclose proglide were associated with a decreased risk of both bleeding and vascular complications. Abbott, 12673, abbott perclose proglide suturemediated. The food and drug administration fda is announcing its approval of the application by perclose, inc. The perclose proglide suturemediated closure system is composed of a plunger, handle, guidewire, and sheath. Two hundred patients undergoing pci were randomized to manual compression, perclose proglide or angio. Your physician has used a closure device called a perclose suture to close your femoral arteryvein after the procedure. Ultrasonography guided percutaneous evar using the. Adjunctive technique for the use of proglide vascular. This system has the broadest arterial and venous indication. You still need to check for haematoma and ooze afterwards as the perclose can and often does fail.
Case 1 a 65yearold male with a history of peripheral arterial disease pad, diabetes mellitus, and coronary artery disease cad, status post bypass grafting presented to vascular surgery with foot pain after peripheral intervention. A hemostasis valve restricts the blood flow through the sheath with or without the guidewire in place. Two perclose proglide devices were generally used per access site, although the number could vary depending on the experience of the operator and the specific condition of the patient. Pdf use of the perclose proglide closure device to remove a. Perclose proglide suturemediated closure smc system delivers a secure, nonmasking percutaneous suture to the access site that promotes primary healing 1 and has no reaccess restrictions. The perclose proglide 6f suturemediated closure system proglide smc is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5f to. With mwire metallurgy and increasing tapers from 2% to over 8% along its active portion, preshaping. Tavi using single versus double perclose proglide devices. The perclose is a stitch that is introduced through the femoral puncture site to. Surgical closure outcomes real world evidence darren b. Preclosure of femoral venous access sites used for largesized sheath insertion with the perclose device in adults undergoing cardiac intervention. Advantages of vascular closure device over manual compression include patient comfort, early mobilisation and discharge, avoidance of. A summary of the arterial closure devices that are currently available for clinical use in the united states. Post care is checking the groin every 15 minutes afterwards like a normal groin post cath, with no perclose.
Cumulative sum analysis of the learning curve for the. Totally percutaneous access using perclose proglide for. Abbott perclose proglide suturemediated closure system. We would like to share our experience in this article. Perclose proglide 6f suturemediated closure smc system. Safety and performance of perclose proglide vascular closure device in managing largehole venous access site. Perclose proglide smc system is commonly used for the following types of. Perclose proglide smc system is commonly used for the following types of procedures. The preclose technique for aaa repair endovascular today. This study evaluated the safety and efficacy of percutaneous endovascular aortic aneurysm repair evar with perclose proglide device.
Proglider is a single file, singleuse glide path file. Abbott laboratories, chicago, il, usa closure device is becoming increasingly prevalent during percutaneous endovascular aortic repair evar and transcatheter aortic valve implantation tavi. Reduced time to hemostasis, ambulation and discharge compared to manual. Ambulation was allowed 3 hr after perclose proglide or angio. Patients undergoing structural heart interventions often require largesized sheath insertion into femoral arteries and veins.
There were 10 failures to deploy perclose proglide and none for angio. The preclose technique using proglide requires the use of two devices for sheath sizes larger than 10 f figure 7a. Preclosure of largesized arterial access sites in adults. This simulator is designed to use for training the perclose proglide.