Medical device study, trials rundown from EuroPCR

Most of the major players in the medical device arena — and a few from off the bench — are busy touting new products and results from a slew of clinical trials at the European Assn. of Percutaneous Cardiovascular Interventions annual conference, EuroPCR 2010:

Abbott (NYSE:ABT):

• New Data Reinforces Safety Profile of Abbott’s Market-Leading XIENCE V Drug Eluting Stent:
  In XIENCE V USA Study, XIENCE V Demonstrates Low Blood Clot Rate at One Year in Real-World Patient Population;
  In SPIRIT V Diabetes Trial, XIENCE V Demonstrates Zero Cases of Stent Thrombosis at One Year in Patients with Diabetes
• Abbott’s Investigational MitraClip System Demonstrates Strong Safety Results and Improved Clinical Outcomes for Common Causes of Leaky Heart Valves:
  Preliminary Results Also Show MitraClip Device Maintains Durability through Two Years in Patients Treated for Mitral Regurgitation
• Abbott’s Groundbreaking Bioresorbable Technology Continues to Demonstrate Exceptional Clinical Results:New Six-Month Data on Abbott’s Bioresorbable Vascular Scaffold Reinforces Its Potential to Be the Next Revolution in Interventional Cardiology

Abiomed Inc. (NSDQ:ABMD):

• Abiomed Reports Updated USpella Results Presented at EuroPCR 2010:
  52% of patients improved New York Heart Association (NYHA) classification by one or more categories after Impella-supported complex PCI. Prior to treatment, 63% of patients were in NYHA class three or four. After treatment, 70% were in NYHA class one or two.

Cordis Corp. [Johnson & Johnson (NYSE:JNJ)]:

• NEVO Sirolimus-Eluting Coronary Stent Continues to Demonstrate Excellent Safety and Efficacy Outcomes in New Twelve-Month Data:
  NEVO, Incorporating RES TECHNOLOGY, Continues to Support Excellent Safety and Efficacy Outcomes vs. the Taxus Liberte According to Data Presented at EuroPCR 2010

InspireMD Ltd.:

• InspireMD Will Provide a Sneak Preview of the Next Generation MGuard Prime, a State of the Art Net Protective Cobalt Chromium Stent System:
  InspireMD is Also Proud to Announce That MGuard is Now Available With an Improved Delivery System. Final 6 Month Results of the MAGICAL Trial and Final 1 Year Results of the INSPIRE Study Will be Presented During EuroPCR 2010

Medtronic Inc. (NYSE:MDT):

• Medtronic CoreValve System Shows Long-Term Efficacy and Durability in Pivotal Trial:
  Market-Leading Transcatheter Aortic Valve Delivers Positive Clinical Outcomes Through Two Years in Major International Study; Achieves 10,000-patient Milestone
• Multiple European Clinical Registries Show Important Benefits of Medtronic CoreValve Transcatheter Aortic Valve System:
  Data Demonstrates That Revolutionary Treatment for Patients with Diseased Heart Valves Is Transitioning Successfully into Standard Clinical Practice throughout Europe
• Medtronic’s Resolute Drug-Eluting Stent Matches Market-Leading Rival in Large Head-to-Head Study:
  One-Year Clinical Results from Innovative RESOLUTE All Comers Trial Show Excellent Performance for Resolute DES in Challenging Patient Population

NMT Medical Inc. (NSDQ:NMTI):

• NMT Medical Launches Rapid Transport Septal Implant Delivery System in France:
  Enhancement Allows Easier Implantation of BioSTAR and STARFlex Devices

NovoStent Corp.:

• NovoStent Announces 6-Month Results of SAMBA Femoropopliteal Trial:
  The SAMBA data showed a 97% Freedom from Target Lesion Revascularization rate. There were no device related complications in any of the 38 patients treated in the trial.

OrbusNeich:

• Data Presented at EuroPCR 2010 Demonstrate Effectiveness of OrbusNeich’s Genous™ Bio-engineered R stent™ in Diabetic Patients:
  OrbusNeich today announced that 12-month follow-up data from a subset analysis of the global e-HEALING registry demonstrate that the company’s Genous Bio-engineered R stent is effective in diabetic patients.

St. Jude Medical Inc. (NYSE:STJ):

• St. Jude Medical Announces Initiation of a Study to Evaluate the Economic Impact of FFR in Europe and Canada:
  Country-specific analysis will evaluate the cost effectiveness of an FFR-guided intervention strategy for patients with multivessel coronary artery disease in the UK, Germany, France, Italy, Switzerland, Belgium and Canada; Unique data from each country will be used to assess the budget and health impact of FFR on its health care system

Tryton Medical Inc.:

• Tryton Announces Positive Data from Side Branch System Presented in Symposium at EuroPCR 2010:
  Tryton Stent Consistently Demonstrates Excellent Results

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