EP Lab Digest - February 2008 - (Page 40)

40 NEWS FEBRUARY 2008 Clinical Study Shows Use of D-Stat Flowable Hemostat Reduced by 48% the Incidence of Clinically Relevant Hematomas in High-Risk, Anticoagulated Patients Undergoing Pulse Generator Implantation Continued from page 1 he study demonstrated that when used as an adjunct to hemostasis in the pre-pectoral pocket during the implantation of pulse generators (i.e., ICDs or pacemakers), D-Stat Flowable reduced the incidence of clinically relevant hematoma formation in high-risk, anticoagulated patients by 48% compared to the standard of care (i.e., electrocautery, standard compression and/or non-treated cotton pledgets). High-risk patients were defined as those whose anticoagulation regimens would resume within 24 hours, including the administration of one or more of the following: heparin, ® T LMWH, warfarin or clopidogrel. For patients receiving warfarin therapy, an INR of ≤2.0 was required for inclusion in the study. The safety of the use of D-Stat Flowable in the pre-pectoral pocket also was successfully demonstrated, as the incidence rate of major complications experienced between the investigation group (D-Stat Flowable: 21.3%) and the control group (standard of care: 27.8%) was similar. The corresponding p-value for non-inferiority was 0.0008, below the a priori alpha level of 0.05, demonstrating non-inferiority of treatment to control for the safety endpoint. The primary effectiveness of D-Stat Flowable within the pre-pectoral pocket was determined by the incidence rate of clinically relevant hematomas. A clinically significant hematoma was defined as alteration in the standard of care (e.g., application of a compression bandage, alteration of the patient’s anti-clotting regime or evacuation of the hematoma). Vascular Solutions, Inc. is a medical device company focused on developing unique solutions for unmet clinical needs in interventional radiology and interventional cardiology. Speedy Procedures Demonstrate Continued Interest in Novel Multi-Electrode Ablation System A blation Frontiers, Inc. announced a successful series of catheter ablations using the company's Tip-Versatile Ablation Catheter ™ (T-VAC). Dr.Vince Paul of the St. Peter's Hospital in Chertsey, United Kingdom is one of three leading European sites that have been evaluating this new multielectrode linear ablation catheter since November 2007. He performed four ablation procedures for atrial flutter. Diagnosed with typical atrial flutter, the patients had all suffered from periodic episodes of palpitations, dizziness, or fatigue. "I would often get lightheaded and notice my heart was racing," said one patient who had tried several medications unsuccessfully. Performed in a cardiac catheterization laboratory, the T-VAC is inserted through a vein in the patient's leg and traversed into the heart. Dr. Paul then moved the catheter tip in the heart until he identified the precise area of cardiac tissue responsible for the irregular heart rhythm. Simultaneously applying radiofrequency (RF) energy to all six T-VAC electrodes with the Ablation Frontiers GENius™ RF Multi-Channel generator, Dr Paul was able to create lesions approximately 30 mm in length. These lesions modify the cardiac tissue to block the abnormal electrical conduction. For one patient, a single ablation created in just 90 seconds completely blocked the short circuit. Another two patients required only two or three ablations to fix their arrhythmia. All four patients were successfully treated and left the catheterization lab with a normal heart rhythm. After the final procedure of the day, which lasted 20 minutes, Dr. Paul said, “With the T-VAC and GENius generator I could create a long contiguous lesion without having to drag the catheter along the surface of the heart. I am very pleased with this novel design, which allows for potentially shorter and safer linear ablations.” Dr. Paul represents one of approximately 10 physicians who will utilize the catheter during an upcoming introduction period. Having received the CE Mark for the T-VAC in September 2007, the T-VAC is expected to be launched into the broad European market in the second quarter of 2008. Ablation Frontiers CEO Keegan Harper said, “The T-VAC will be a strong complement to our other product offerings and allow us to offer advanced treatment to all patients needing an ablation therapy whether it be in the right or left side of the heart. The T-VAC will also enable treating physicians to perform ablation procedures in substantially less time than what is currently possible.” Federal Law limits these devices to investigational use in the United States.

Table of Contents Feed for the Digital Edition of EP Lab Digest - February 2008

EP Lab Digest - February 2008 Creating the U-M Center for Arrhythmia Research: Interview with José Jalife, MD Texas Cardiac Arrhythmia Institute and St. David’s Medical Center Launch State-of-the-Art Training Center Contents Letter from the Editor Spotlight Interview: Caritas St. Elizabeth’s Medical Center 10-Minute Interview: Sue Deck, BS, RN, RCES Keeping Pace With a Blog Roundtable Discussion on Cryoablation Procedures Email Discussion Group: February 2008 Events Calendar Industry News and Products Classifieds Advertisers Index

EP Lab Digest - February 2008

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