MicroPort CRM initiates a clinical trial for breakthrough innovative left ventricular lead Axone(TM)

PARIS,Dec. 10,2020 -- MicroPort Cardio Rhythm Management (CRM) has announced the first enrollment in the Astral-4LV clinical trial[1] to evaluate the safety and efficiency of Axone™,a breakthrough innovative quadripolar left ventricular lead. Axone™ is designed for use in heart failure patients with Cardiac Resynchronisation Therapy (CRT) indications that require the implantation of a CRT pacemaker (CRT-P) or CRT implantable defibrillator (CRT-D).

The purpose of this study is to assess the chronic safety and performance of the Axone™ lead for cardiac resynchronization therapy (CRT). CRT requires a pacing lead to be positioned in the coronary venous system of the left ventricular (LV). The Axone™ lead has a diameter of 0.4mm,which is about 4 times smaller than the diameter of a standard LV lead,and has been designed to better navigate in narrow and tortuous coronary veins.

Axone™ also features four widely-spaced electrodes,which may offer more options for LV pacing sites and allow multipoint pacing with distant electrodes (bi-zone pacing),for potentially broader resynchronization.

The first implantation of the Axone lead as part of the Astral-4LV study was successfully performed on December 3,2020,by Professor Frédéric Anselme,main investigator,from University Hospital of Rouen,France.

"Approximately 30% of patients do not respond to CRT therapy[2],and one of the main reasons is the difficulty of being able to pace the left ventricle in the correct locations," said Professor Frédéric Anselme. "Axone™ makes it possible to find left ventricular pacing sites that are inaccessible with standard leads. Axone™ is what we needed to improve the response rate to CRT and have a positive impact on patient outcomes."

Astral-4LV is a prospective,single arm,multicenter clinical trial that will enroll 152 patients at 20 centres in France,Germany,Italy,Netherlands,Portugal,Spain,and Austria.

"We continue to invest in innovative technologies and support clinical trials that provide the strongest possible evidence of safety and efficacy for our therapies," said Benoît Clinchamps,President of MicroPort CRM. "The Axone™ lead and Astral-4LV clinical study highlight our commitment to improving the quality of life of patients and saving more lives. We strongly believe that Axone™ has the potential to be a major breakthrough in the treatment of heart failure through resynchronization therapy."

The primary objectives are the related complication free rate and the success rate of left ventricular pacing. A secondary objective of the Astral-4LV study evaluates the success rate of a bi-zone left ventricular pacing. The study data will be used to support CE marking of Axone™. The primary endpoints will be evaluated at 6-month post-implantation and the patients will be followed for 4 years.

The Axone Project has received funding from the European Union's Horizon 2020 research and innovation program. MicroPort CRM is leading the project in collaboration with Heraeus GmbH,the University Hospital of Rouen,France,and Maastricht University,Netherlands.

About Cardiac Resynchronization Therapy (CRT)

CRT therapy is indicated in heart failure patients with cardiac desynchronization. The CRT devices are implanted under the skin,in the chest area,and are connected to the heart by three transvenous pacing leads that conduct electrical impulses to pace the heart. The pacing leads are positioned in the right atrium,right ventricle and left ventricle. The electric stimulation of the cardiac chambers triggering their contractions is synchronized in order to restore a better pumping efficiency of the heart. The CRT therapy has been demonstrated to improve survival and quality of life,and to reduce hospitalization in heart failure patients[3].

About MicroPort CRM

MicroPort CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM),whose world headquarters are in Clamart,near Paris,France. Through our long-standing expertise in CRM,MicroPort CRM develops,manufactures and markets cardiac pacemakers,implantable cardiac defibrillators,cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure. Our state-of-the-art products are manufactured in Clamart,Saluggia,and in Santo Domingo,Dominican Republic.

For more information,please refer to: www.microport.com

1:https://clinicaltrials.gov/ct2/show/NCT04463641

2 : Auricchio A,Prinzen FW. Non-responders to cardiac resynchronization therapy. Circulation 2011;75:521–527.

3: Abraham WT,Fisher WG,Smith AL,Delurgio DB,Leon AR,Loh E,Kocovic DZ,Packer M,Clavell AL,Hayes DL,Ellestad M,Trupp RJ,Underwood J,Pickering F,Truex C,McAtee P,Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346:1845–1853.