EXTON, Pa., Nov. 7 /PRNewswire-FirstCall/ -- Kensey Nash Corporation today announced it has completed enrollment in the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study for the new TriActiv(R) FX(TM) System. ASPIRE is a multi-center, prospective registry, designed to support regulatory clearance of the TriActiv(R) FX(TM) System in the U.S. for a saphenous vein graft (SVG) indication. The Company expects to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) for the new TriActiv(R) FX(TM) System within 90 days.
“I am pleased to report that the early data collected from the ASPIRE study is compelling,” stated Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. “We believe this study will significantly reinforce our belief that balloon protection provides the most effective means of preventing unwanted debris from migrating distally to the microvasculature. We look forward to reporting these results to the medical community, as soon as they are available,” he added.
“Furthermore, the enrollment rate in the ASPIRE Study exceeded our expectations, and reflected the enthusiasm from both the U.S. and German physician investigators who participated in this study for the new TriActiv(R) System. This allowed us to complete the study two months earlier than originally expected,” Mr. Kaufmann said.
The TriActiv(R) FX(TM) System incorporates several important ease-of-use design enhancements to the TriActiv(R) System platform. These include a new balloon inflator that simplifies catheter exchanges during the procedure, and a new flush catheter design to enhance device usage and reduce procedure time.
“We were very impressed by the performance of this new device, particularly in challenging cases,” commented Dr. Chris Metzger, co-Principal Investigator of the Study, about the TriActiv(R) FX(TM) System. “I am a believer in balloon protection as the best solution for protecting the microvasculature from all potentially dangerous emboli during interventions. This new system with its innovative inflation system dramatically improves ease of use and will facilitate its adoption in our practices,” he concluded.
“My experience with the new TriActiv(R) FX(TM) System is quite favorable,” commented Dr. Michael Haude, Universitatsklinikum Essen, Germany, who was one of the top enrollers in the study. “Kensey Nash has incorporated all the best tools for embolic protection in one system. We were pleased to have participated in the study of its clinical efficacy and are looking forward to seeing the results,” he concluded.
The Co-Principal Investigators of the ASPIRE Study are Drs. Christopher Metzger, Wellmont Holston Valley Medical Center, Kingsport, TN and Joseph Carrozza, Beth Israel Deaconess Medical Center, Boston, MA. Approximately 20 centers participated in the study, which enrolled over 100 patients.
The TriActiv(R) System is currently indicated to prevent heart attacks during the interventional treatment of saphenous vein grafts (SVGs) in patients who previously received coronary bypass surgery, but now have blockages in the grafts. The device incorporates three important features to address the common problem of distal embolization - a protection balloon guidewire that creates a protected space, a flush catheter that washes the graft, and an automated extraction system that removes the debris found in the graft. These three features work in combination to prevent the debris, found in the graft, from embolizing and potentially causing a heart attack. The TriActiv(R) ProGuard(TM) System is a new version of the System that is being studied in the carotid anatomy.
About Kensey Nash Corporation. Kensey Nash Corporation is a leading developer and manufacturer of absorbable biomaterials-based products with applications in the cardiology, orthopaedics, spine, drug and biologics delivery, periodontal/dental, surgical and wound care markets. The Company was a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal(TM) Vascular Closure Device, which is licensed to St. Jude Medical, Inc. The TriActiv(R) System, a novel embolic protection system, is cleared for sale in the U.S. The TriActiv(R) FX(TM) System, the second generation of the TriActiv(R) System, is approved for sale in the European Union and has been studied in a clinical trial to gain regulatory clearance in the U.S.
Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect Kensey Nash’s current expectations about its prospects and opportunities, including, without limitation, expectations regarding Kensey Nash’s TriActiv(R) System. Kensey Nash has tried to identify these forward-looking statements by using words such as “believe,” “expects,” “anticipates,” “will,” “should” or similar expressions, but these words are not the exclusive means for identifying such statements. Kensey Nash cautions that a number of risks, uncertainties, and other important factors could cause Kensey Nash’s actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements, including, without limitation, the ability of Kensey Nash to successfully market the TriActiv(R) System and competition from other technologies in the embolic protection market. For a more detailed discussion of these and other factors, please see Kensey Nash’s filings with the Securities and Exchange Commission. Except as expressly required by the federal securities laws, Kensey Nash undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.
Kensey Nash Corporation
CONTACT: Joseph W. Kaufmann, President and Chief Executive Officer, KenseyNash Corporation, +1-610-524-0188
Web site: http://www.kenseynash.com/
