Cath Lab Digest

Abbott Vascular Devices Launches Perclose® ProGlide Next Generation Suture-Mediated Vessel Closure System

Abbott Vascular Devices, a division of Abbott Laboratories, announced the launch of the next generation Perclose® suture-mediated vessel closure system, Perclose ProGlide, featuring polypropylene monofilament suture. The device received approval from the U.S. Food and Drug Administration (FDA) during the first quarter of 2004. Perclose closure devices are designed to close femoral artery puncture sites following diagnostic or interventional procedures.

With monofilament suture, the ProGlide knot advances to the opening in the artery, allowing a single operator to deliver a pre-tied knot to close the access site in the femoral artery following a catheterization procedure. This stitch provides rapid hemostasis and allows patients to recover comfortably by providing the ability to get out of bed in a shorter amount of time. Monofilament suture is also a preferred suture for vascular surgeons due to its high-knotted tensile strength and minimized tissue reaction.

Additional features on Perclose ProGlide include the QuickCut mechanism, which is built into the device to trim the suture after deployment, making it unnecessary to use additional sharps during the procedure. The trimmer facilitates both suture trimming and knot advancement, eliminating a potentially time-consuming step in the vessel closure procedure for many operators. ProGlide also features numbered procedure deployment steps that are printed on the device.

In addition, the FDA approved new product labeling for Perclose ProGlide that states there are no reaccess/repuncture restrictions if previous arteriotomy repairs were achieved with a Perclose suture-mediated closure device. This product labeling for Abbott Vascular Devices’ Perclose closure products allows physicians to perform repeat procedures using the same access site immediately.

Abbott Vascular Devices has also begun offering a Continuing Education Unit (CEU) course for nurses and technologists. The course, titled Building a Pathway for Better Patient Outcomes, focuses on the importance of proper access site management in catheter-based procedures and is available as either a one- or four-credit course. More information is available on this educational course by visiting www.abbottvasculardevices.com.

American Heart Association research indicates that more than 61 million Americans have cardiovascular disease, and nearly 3 million cardiac catheterizations are conducted in the United States each year.

The Perclose ProGlide 6F Suture-Mediated Closure (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 8F sheaths. The Perclose ProGlide SMC System should only be used by physicians (or other health care professionals authorized by or under the direction of such physicians) who have been trained in the use of the Perclose ProGlide SMC System, e.g., participation in the Perclose ProGlide SMC System training program or equivalent.

Witt Biomedical Delivers New ECG Management System

Witt Biomedical Corporation has received clearance to market a new ECG management software program designed and targeted at hospitals that desire to combine electrocardiograms (ECGs) with an enterprise cardiac PACS solution as well as to clinics and physician offices that desire a scalable, cost-effective ECG management solution. Witt’s Calysto for ECG Management program combines original 12-lead ECG data with clinical/image data from the cath lab, echocardiography and nuclear medicine into a single cardiac record. For those who are interested in only an electronic paperless ECG review and archival, Calysto for ECG Management can be a cost-effective solution.

Calysto ECG Management provides a non-proprietary method of obtaining original ECG patient data and interpretive statements that are imported directly from vendor neutral host ECG carts and automatically integrated with all other information within the electronic patient record. The new program allows for a solution to the retrieval and review of ECG data on a single or dual monitor workstation.

With the new Calysto for ECG Management program, the physician opens the locator window on his/her PC monitor, sets the modality filter to compile his/her patients’ ECGs, reviews the interpretive statements and clicks the confirm button, if there are no changes. The word Confirmed automatically appears in the upper right hand corner of the screen.

Dual Screen mode allows physicians simultaneous review and analysis, and a Historical Comparison viewing mode offers immediate review of current, as well as previous ECG studies. Post processing analysis features provide additional tools such as electronic calipers for performing or recalculating measurements. In printing ECGs, Calysto ECG Management provides for standard 12-lead format as well as different user configurations and final reports, delivered to the work areas where you need them. Automated Word Transcription with unlimited report templates permits report generation for those that desire a full report.

When combined with Witt’s WebDV feature, ECG Management offers anytime/anywhere access as convenient as the nearest PC. Authorized users are able to access ECGs, cardiology images, data and reports, with a standard browser and web server.

Witt’s ECG Management program is fully compatible with HIPAA security and privacy standards.

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