BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Results from a Cordis analysis presented at the 14th Annual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) congress in Madrid indicates use of EXOSEALTM Vascular Closure Devices in patients undergoing percutaneous coronary interventions (PCI) may result in important cost-savings for U.S. hospitals, as compared to combined use of ANGIO-SEALTM, MYNXTM, PERCLOSETM, and STARCLOSETM Vascular Closure Devices*(VCDs).
Results predicted that use of EXOSEALTM, compared to U.S.-reported use of four other VCDs (ANGIO-SEALTM, MYNXTM, PERCLOSETM, and STARCLOSETM), is associated with cost-savings of approximately $70 USD per procedure and $70,240 USD per 1,000 annual PCI procedures. Extrapolation of these findings to the estimated 550,000 PCI procedures utilizing VCDs in the U.S. each year results in a predicted annual cost-savings of approximately $38 million USD for the U.S. hospital system. These predictions do not consider the potential cost-savings that may be realized from use of EXOSEALTM in other types of procedures (i.e., diagnostic coronary or peripheral). Details are available in ISPOR Outcomes Research Digest.
This analysis supports the growing need to assess the economic value of VCDs. “The rapid evolution of VCD technology has resulted in a lack of direct comparative data that poses challenges for hospital decision-makers,” said Ryan Saadi, M.D., M.P. H., Worldwide Vice President of Health Economics and Strategic Pricing. “This analysis addresses the data gap by combining the use of indirect comparison methods and modeling techniques to estimate costs of current use of VCDs vs. EXOSEALTM on both a hospital and nation-wide level. We look forward to further data regarding use of EXOSEALTM in real-world settings, and to incorporating these findings into future analyses.”
The analysis was based on clinical trial data that reported safety results in patients undergoing vascular closure with EXOSEALTM. Complication risks** reported in these trials were compared, using an indirect comparison framework, to risks reported in manufacturer-sponsored prospective clinical studies for other VCDs, as stated in product Instructions for Use. This clinical data was used in the model along with a static risk of clinical consequences of these complications (i.e., amputation, vascular surgery, endovascular procedure, transfusion, ultrasound-guided intervention) and associated hospital-related US consequence costs available in the scientific literature. The one-year budget-impact was estimated assuming 100% use of EXOSEALTM vs. current U.S.-reported VCD market-share (i.e., ANGIO-SEALTM: 50.6%; PERCLOSETM: 21.2%; STARCLOSETM: 19.4%; MYNXTM: 8.8%)***. Supply costs related to the EXOSEALTM were assumed equal. For the US hospital system, the predicted yearly cost-savings of $38,631,949 USD results from a cost-savings of $70 USD per procedure due to avoided complication consequences (i.e., for 550,000 patients).
EXOSEAL™ is a VCD indicated for use in femoral artery puncture site closure, reducing time to hemostasis (TTH) and time to ambulation (TTA) in patients who have undergone diagnostic or interventional procedures using a standard 5F, 6F, or 7F vascular sheath introducer with up to a 12 cm working length. EXOSEAL™ is also indicated to reduce TTH and TTA in patients who have received pre-procedural and/or intra-procedural glycoprotein IIb/IIIa inhibitor therapy undergoing interventional catheterization procedures using a standard 6F vascular sheath introducer with up to a 12 cm working length. EXOSEAL received FDA approval in May, 2011. It is available for commercial sale in more than 30 countries worldwide.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.
* The third party trademarks used herein are trademarks of their respective owners.
** Complication risk for occlusion, infection, retroperitoneal hemorrhage, pseudoaneurysm, other access-site bleeds, and arteriovenous fistula were calculated for each VCD as follows: EXOSEALTM [0.00%, 0.00%, 0.56%, 0.00%, 0.00%, 0.00%], ANGIO-SEALTM [0.33%, 0.00%, 0.33%, 0.00%, 0.00%, 0.33%], MYNX™ [0.00%, 0.00%, 0.00%, 0.53%, 0.53%, 0.00%], PERCLOSE™ [0.00%, 0.78%, 0.52%, 0.26%, 0.52%, 0.00%] and STARCLOSETM [0.20%, 0.00%, 0.00%, 0.20%, 0.41%, 0.00%].
***Market Research Group; 2010 Data
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