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Elixir Medical Corporation to Announce 6-month Results of the DESolve Fully Bioresorbable Coronary Scaffold System Pivotal Trial at Late Breaking Trial Session of EuroPCR

2013年05月01日 PM08:25
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SUNNYVALE, Calif.

Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it will release six-month pivotal, clinical trial results for its fully bioresorbable drug-eluting scaffold system, the DESolve® Bioresorbable Coronary Scaffold, at the EuroPCR session of “From Late Breaking Trial to Clinical Practice” in Paris on Tues., May 21st 2013, in the Main Arena of the conference. EuroPCR is the official annual meeting of the European Association for Percutaneous Cardiovascular Interventions.

The multi-center, prospective DESolve Nx Trial was designed to enroll 120 patients at 15 centers in Germany, Belgium, Poland, Brazil and New Zealand. The primary safety endpoint of the DESolve Nx trial is the composite of major adverse cardiac events (MACE) comprised of cardiac death, target vessel myocardial infarction (MI) and clinically-indicated target vessel revascularization (TLR). The primary angiographic endpoint of the trial is in-scaffold late lumen loss at 6 months as assessed by QCA (quantitative coronary angiography). In a sub-set of patients, additional QCA assessment will be conducted at 24 months; scaffold and vessel assessment using IVUS (Intravascular Ultrasound), OCT (Optical Coherent Tomography) were to be conducted at baseline, 6 and 24 months; and MSCT (Multi Slice Computed Tomography) at 12 months thus providing long-term assessment of the scaffold and surrounding vessel.

Elixir will also announce additional new data on its fully bioresorbable scaffold and other drug eluting stent platforms during the conference. Following are some of the highlights of Elixir Medical’s programs and activities at the EuroPCR conference (in chronological order) at the Palais Des Congres de Paris in Central European Summer Time (CEST):

 

Tuesday, May 21: 15:38 – 15:50, Main Arena

    Session: From Late Breaking Trial to Clinical Practice

First report of results from the pivotal DESolve Nx trial: 6-month clinical and multimodality imaging results

• Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

 

Thursday, May 23: 10:35 – 10:45, Room 242AB

Session: Pre-clinical Studies of Upcoming Bioresorbable Scaffolds

Preclinical evaluation of a Novolimus-eluting stent

• Stefan Verheye, MD, PhD, ZNA Middleheim Hospital, Antwerp, Belgium

 

Thursday, May 23: 12:00 – 13:30, Room 241

Elixir Medical Symposium

Innovating vascular restoration: Paving the way for the DESolve scaffold platform

Chairpersons:

• Martin B. Leon, MD, New York – Presbyterian Hospital / Columbia University Medical Center, New York, NY, USA

• Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

Faculty:

• John Ormiston, MBChB, Mercy Angiographic Unit, Auckland, New Zealand

• Stefan Verheye, MD, PhD, ZNA Middleheim Hospital, Antwerp, Belgium

• Bernhard Witzenbichler, MD, Charite – Campus Benjamin Franklin, Berlin, Germany

 

Thursday, May 23: 15:52 – 16:00, Room 351

Session: Bioresorbable Scaffolds, Clinical Results

Prospective, Multi-Center Evaluation of the DESolve Nx Novolimus Eluting Bioresorbable Coronary Scaffold: First Report of Principal Clinical and Imaging Endpoints

• Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

 

Thursday, May 23: 16:45 – 16:52, Room 253

Session: New Generation DES comparison with older DES

Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation of the Elixir DESyne® Novolimus Eluting Coronary Stent System with Durable Polymer Compared to the Endeavor Zotarolimus Eluting Coronary Stent System: Long Term (3 year) results from the EXCELLA II Trial

• Bernhard Witzenbichler, MD, Charite – Campus Benjamin Franklin, Berlin, Germany

 

Friday, May 24: 09:56 – 10:03, Room 241

Session: Bioresorbable vs. Durable Polymer coating for DES

Multi Center, Prospective, Randomized, Single Blind, Consecutive Enrollment Evaluation a Novolimus Eluting Coronary Stent System with Bioabsorbable Polymer Compared to a Zotarolimus Eluting Coronary Stent System: Long Term (24-month) Clinical Follow Up from the EXCELLA BD Trial

• Ricardo Costa, MD, PhD, Institute of Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

 

Friday, May 24: 11:21 – 11:29, Room 242A

Session: Bioresorbable Scaffolds – lessons learnt from intra-coronary imaging

Six-month Intravascular Ultrasound (IVUS) Analysis of DESolve Nx, a novel PLLA-based drug eluting bioresorbable vascular scaffold: IVUS Results from the prospective, multicenter DESolve NX Trial

• Jose Costa, MD, Institute of Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

 

Friday, May 24: 11:33 – 11:41, Room 242A

Session: Bioresorbable Scaffolds – lessons learnt from intra-coronary imaging

Evaluation of the novel Novolimus eluting bioresorbable vascular scaffold for treatment of de novo coronary artery stenosis: serial optical coherence tomography analysis of the DESolve NX study

• Daniel Chamie, MD, PhD, Institute of Dante Pazzanese de Cardiologia, Sao Paulo, Brazil

 

Elixir Medical will also have 5 poster presentations in the Poster Area and the Moderated Poster Area on Wed., May 22.

Elixir Medical will have a booth at EuroPCR: Booth # F5, Second Floor. The booth will be open Tues., May 21 through Fri., May 24.

About Elixir Medical

Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company’s next-generation drug-eluting stent systems and bioresorbable coronary scaffold are designed to optimize localized drug delivery to provide safe and effective treatments for cardiovascular patients. For more information, visit www.elixirmedical.com.

CONTACT

Elixir Medical Corporation
Vinayak Bhat, Ph.D., 408-636-2006

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