28.06.2006 19:00:00
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Journal of Invasive Cardiology Publishes New Results on Use of the Possis AngioJet(R) System in High-Risk Coronary Patients
Possis Medical, Inc. (NASDAQ:POSS) today announced that importantnew observational studies of its AngioJet(R) Thrombectomy System fortreating heart attack patients are being published as a supplement tothe July issue of The Journal of Invasive Cardiology. The supplementdetails "real-world" results from five patient registries presented bya Panel of leading interventional cardiologists during the March 2006annual convention of the American College of Cardiology (ACC) inAtlanta.
These registry results led the Panel to conclude in part that "useof the AngioJet with primary percutaneous catheter-based intervention(PCI) is safe and suggest that the AngioJet may improve procedural andclinical outcomes in a broad spectrum of real-world ST-elevationmyocardial infarction (STEMI) patients treated with primary PCI."
"The patient registries highlighted in this supplement show theeffectiveness and safety of using AngioJet to treat heart attackpatients with large thrombus," said Robert G. Dutcher, CEO of PossisMedical. "This is an important step in helping physicians understandthe clinical value AngioJet brings to the treatment of coronarythrombus in a variety of settings."
The interventional cardiologists comprising the Panel include: Dr.Georgios Sianos, Thoraxcenter, Rotterdam, The Netherlands; Dr. SaminSharma, Mount Sinai Hospital, New York City; Dr. Ray Matthews, GoodSamaritan Hospital, Los Angeles; Dr. Simon Dixon, Beaumont Hospital,Royal Oak, Mich.; Dr. Charles Simonton, Carolinas Heart Institute,Charlotte, North Carolina; and Dr. David Antoniucci, CareggiInstitute, Florence, Italy. The Panel was co-moderated by Dr. DonaldBaim, Brigham and Women's Hospital and Harvard Medical School, Boston,Mass., and Dr. Bruce Brodie, Moses Cone Heart and Vascular Center,Greensboro, North Carolina.
Writing in the supplement, the Panel also commented on thefavorable results of these registries compared to the AiMI trialresults announced in 2004: "In the AiMI trial, the mortality and majoradverse cardiac events (MACE) rates were higher with rheolyticthrombectomy than with the control. However, the study was not poweredto detect differences in clinical events, so the findings were quitesurprising. The differences in mortality were not due to a highmortality in the AngioJet arm, but rather to an unexpectedly lowmortality in the control arm (0.8%, lower than any previously reportedprimary PCI trial). The data and safety monitoring committee reviewedthe deaths in the trial and did not find that any of the deaths weredirectly attributed to device use. Based on these considerations andthe results of the five registries (presented at the Panel), all ofwhich found equivalent or lower mortality and MACE rates withAngioJet, it does not appear that safety is an issue with theAngioJet."
Dutcher noted another possible benefit of this and other recentlyreported clinical experience with AngioJet to treat coronary thrombus."In a June 22 article, the Wall Street Journal reported that some U.S.hospitals are decreasing their use of drug-eluting stents because ofrising concern over rates of late stent thrombosis among patients whoreceive them. The important work by Dr. Sianos which he recentlypresented at the May EuroPCR conference in Paris, and which weannounced in a May 18 press release, shows that AngioJet thrombectomybefore treatment with drug-eluting stents in heart attack patientspresenting with large thrombus markedly reduces the observed incidenceof stent rethrombosis in follow-up out to two years."
Concluded Dutcher, "We expect that these results, coupled withthis new Supplement's conclusion that AngioJet may be safely used insuch patients, should further build the confidence of our cardiologycustomers, and will, in combination with additional new clinicalscience and our upcoming JETSTENT trial, further position AngioJet andPossis Medical for long-term success."
About Possis Medical, Inc.
Possis Medical, Inc., develops, manufactures and marketspioneering medical devices for the large and growing cardiovascularand vascular treatment markets. The AngioJet(R) Rheolytic(TM)Thrombectomy System is marketed in the United States for blood clotremoval from native coronary arteries, leg arteries, coronary bypassgrafts and AV dialysis access grafts.
Certain statements in this press release constitute"forward-looking statements" within the meaning of Federal SecuritiesLaws. Some of these statements relate to clinical initiatives and thecontinuing impact from the results of the AiMI trial. These statementsare based on our current expectations and assumptions, and entailvarious risks and uncertainties that could cause actual results todiffer materially from those expressed in such forward-lookingstatements, such as, the effectiveness of our sales and marketingefforts in re-establishing coronary product usage and our ability togenerate suitable clinical registry data to support growing use of theAngioJet in coronary applications. A discussion of these and otherfactors that could impact the Company's future results are set forthin the cautionary statements included in the Company's Form 10-K forthe year ended July 31, 2005, filed with the Securities and ExchangeCommission.
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