- Dr. James Isobe presented data today at the American Venous Forum annual meeting in New Orleans reflecting his experience using Vascular Solutions' reprocessing service for ClosureFAST catheters.
- The study compared outcomes from the use of new vs. reprocessed ClosureFAST radiofrequency vein ablation catheters in 595 procedures in 302 patients treated in an outpatient office setting during a 12-month period.
- Based on the outcomes, Dr. Isobe concluded that the performance of a reprocessed ClosureFAST catheter is equivalent to a new catheter.
- Dr. Isobe also reported substantial cost savings from the use of reprocessed ClosureFAST catheters.
NEW ORLEANS, Feb. 19, 2014 (GLOBE NEWSWIRE) -- Dr. James Isobe of the Baptist Vein Center in Birmingham, Alabama today reported positive clinical outcomes and significant cost savings associated with the use of Vascular Solutions, Inc.'s (Nasdaq:VASC) reprocessing service for the ClosureFAST radiofrequency ablation catheters in the treatment of superficial venous incompetence.
Dr. Isobe made his presentation, "12 Month Experience Using Reprocessed ClosureFAST Radiofrequency Catheters", during the Scientific Sessions of the 26th Annual Meeting of the American Venous Forum in New Orleans. The study evaluated the performance and clinical outcomes resulting from the use of reprocessed ClosureFAST catheters compared to new ClosureFAST catheters in patients treated by Dr. Isobe in an outpatient setting at Baptist Vein Center between August of 2012 and July of 2013.
Dr. Isobe conducted his treatments in 302 consecutive patients with primary venous incompetence in the Great Saphenous Vein (GSV), Small Saphenous Vein (SSV), or accessory veins in one or both legs. During the 12-month period, Dr. Isobe performed a total of 595 procedures, with 198 using new ClosureFAST catheters and 397 using ClosureFAST catheters that had been reprocessed by Northeast Scientific, Inc. as part of the reprocessing service offered by Vascular Solutions. Follow-up examinations were conducted two weeks and six months after each treatment. Based on the standard method for assessing changes in disease severity over time, Dr. Isobe concluded that the performance of a reprocessed ClosureFAST catheter is equivalent to a new catheter in the treatment of superficial venous incompetence.
The two-week and six-month follow up consisted of a color flow duplex ultrasound study of the deep system, checking for deep vein thrombosis (DVT), and examining the ablated veins for endovenous heat-induced thrombosis and recanalization. The DVT rate was similarly low in both groups, Dr. Isobe reported, with four cases out of 198 procedures among patients treated with new ClosureFAST catheters and four cases out of 397 procedures among patients treated with the reprocessed catheters. The inflammatory responses were similar in both treatment groups, Dr. Isobe said, and in all of these cases the skin redness and pain were resolved by treatment with a common oral antibiotic for ten days.
The Venous Clinical Severity Score (VCSS) was used to rate the severity of disease before treatment and at the time of the follow up examinations. The VCSS score rates the severity of disease on a scale of 0-30. The pre-operative VCSS in both the new and reprocessed catheter treatment groups decreased at the two-week and six-month follow up, Dr. Isobe reported. From average pre-operative VCSS scores of 5.37 in the new catheter treatment group and 5.97 in the reprocessed catheter treatment group, the ratings of disease severity declined to average scores of 2.62 and 3.03, respectively, after two weeks. At six months, according to Dr. Isobe's data, the degree of severity had decreased by 3.6 points in both groups of patients.
In addition to the positive clinical performance of the reprocessed ClosureFAST catheters, Dr. Isobe reported that his clinic achieved a cost-savings of $70,666 with the use of the reprocessing service during the 12-month period of the study.
The ClosureFAST radiofrequency ablation catheter, which is manufactured and marketed by Covidien, is the most popular product used for performing endovenous therapy for the treatment of varicose veins in the U.S. Reprocessing of the ClosureFAST catheter is a service offered exclusively by Vascular Solutions in collaboration with Northeast Scientific, an established third-party reprocessor of medical devices. NES received 510(k) clearance from the U.S. Food and Drug Administration on November 30, 2011 for reprocessing the ClosureFAST catheter.
Dr. Isobe's research was not sponsored by Vascular Solutions or NES, and Dr. Isobe did not receive any remuneration associated with the study from either party. Dr. Isobe, who has more than 30 years of experience as a surgeon, is Board Certified in General Surgery by the American Board of Surgery, a Fellow of the American College of Surgeons, a Registered Vascular Technologist, and a Diplomate of the American Board of Phlebology.
"We are grateful to Dr. Isobe for making the results of his study available to his peers in the vein therapy community. His study confirms our view and the experience of many other physicians that the use of reprocessed ClosureFAST catheters is a safe and effective practice," said Howard Root, Chief Executive Officer of Vascular Solutions. "Dr. Isobe's study also underscores the significant cost savings that can be derived from reprocessing. Since we launched our reprocessing service in January of 2012, more than 500 U.S. vein clinics have contracted to use the service in pursuit of the goal of reducing their costs and cutting down on medical waste. During that time, we have demonstrated an excellent safety record, with more than 45,000 catheters successfully reprocessed and no serious adverse patient events reported."
Vascular Solutions markets and sells the ClosureFAST reprocessing service to hospitals and clinics in the United States through Vascular Solutions' 91-person direct sales force. Subscribers to the service send their used ClosureFAST catheters directly to NES for reprocessing. NES's validated reprocessing system for ClosureFAST involves multiple stages, including decontamination, cleaning, drying, packaging, labeling, sterilization, and biological quarantine testing. As part of the process, each catheter is subjected to function testing and undergoes multiple inspections to ensure that quality standards are met.
About Northeast Scientific
Northeast Scientific, Inc. (NES), a privately-held company headquartered in Waterbury, Connecticut, is registered with the U.S. Food and Drug Administration as a reprocessor of single-use medical devices. Founded in 2005, NES received its first 510(k) clearance in 2007. NES's facility was designed specifically to reprocess single-use devices. The process employs a high capacity reverse osmosis deionized water system for cleaning, and only environmentally safe detergents are used. NES performs all sterilization in-house using 100% ethylene oxide systems that limit waste and ensure sterility. Functional testing of each reprocessed device and heat-seal packaging is carried out in NES's Class 10,000 clean room. For more information about NES, visit the company's website at www.mdreprocess.com.
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company's product line consists of more than 80 products in three categories: catheter products, hemostat products and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.
The information in this press release contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2013 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of our new products, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
ClosureFast is a registered trademark of Covidien LP Limited Partnership. Reprocessing of ClosureFast catheters is performed by Northeast Scientific and is not affiliated in any way with Covidien.
For further information, connect to www.vasc.com.
CONTACT: Phil Nalbone, VP-Corp. Dev. PNalbone@vasc.com (763) 656-4371Source:Vascular Solutions, Inc.