Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA System

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Endologix LLC , a privately held global medical device company dedicated to improving patients lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.

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Retrieved on: 
Thursday, August 4, 2022
Information
Tags: 
Health, Medical Devices, Cardiology, MDD, Freedom, Union, Vascular disease, Patient, PAD, AFX, AAA, Quality, Safety, European Commission, Moyamoya disease, Medical Devices Directive, Randomized controlled trial, Technology, Aortic aneurysm, Aneurysm, Forward-looking statement, CEO, Certification, EVAR, Royal commission, Medical device, Acquisition, MDR, EU
Geotags: 
UNITED STATES, NORTH AMERICA, CALIFORNIA, EUROPEAN UNION
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ENDOLOGIX, DEERFIELD MANAGEMENT
Summary
Key Points: 
  • Endologix LLC , a privately held global medical device company dedicated to improving patients lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System.
  • CE Mark certification under the new requirements is a high-bar and we are proud of this significant company achievement.
  • Meeting the rigor of the new framework is an important milestone for our AFX2 System, said Elisa Hebb, Endologixs EVP of Medical, Clinical, Regulatory Affairs and Quality.
  • Endologixs current commercial EVAR products include the AFX2 Endovascular AAA System and the ALTO Abdominal Stent Graft System.


Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives with innovative interventional treatments for vascular disease, announced that is has received CE Mark Certification under the new EU Medical Devices Regulation [EU-MDR [(Regulation (EU) 2017/745)] for its AFX2 Endovascular AAA System. The EU-MDR is a regulation for medical devices applied by the European Commission, released in 2017 and effective as of May 26, 2021. It replaces the Medical Devices Directive (MDD). The intent of the EU MDR is to ensure a high standard of safety and quality for medical devices that are produced in, or supplied to, member countries of the European Union.

“CE Mark certification under the new requirements is a high-bar and we are proud of this significant company achievement. Meeting the rigor of the new framework is an important milestone for our AFX2 System,” said Elisa Hebb, Endologix’s EVP of Medical, Clinical, Regulatory Affairs and Quality.

“We believe AFX2 offers an innovative solution for AAA and continues to play a significant role in clinical practice due to its differentiated design features and the compendium of clinical evidence,” said Matt Thompson, President, and CEO of Endologix, “We are committed to investing in clinical research to evaluate the long-term outcomes of our products. Evidence to date supports the comparative effectiveness of AFX2 in the treatment of patients with abdominal aneurysms.”

The currently marketed AFX2 System was introduced in 2016 and its comparative performance is studied in the LEOPARD Randomized Controlled Trial. The study was designed to directly compare AFX2 and the predecessor AFX device, to other commercially available endografts. The five-year results of this study will be available later this year, while the four-year results demonstrated that freedom from aneurysm related complications was similar between the AFX and AFX2 cohort and comparator endografts.

About Endologix

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX®2 Endovascular AAA System and the ALTO® Abdominal Stent Graft System. Endologix became a private company, wholly owned by Deerfield Management in October 2020. In April 2021, Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology company pioneering a first-of-its-kind technology to address an unmet need for new treatments for severe peripheral arterial disease (PAD).

The company has offices and manufacturing sites in Irvine, Santa Rosa and Milpitas California. To learn more about Endologix, please visit http://www.endologix.com/.

About Deerfield Management

Deerfield is an investment management firm committed to advancing healthcare through investment, information, and philanthropy. For more information, please visit www.deerfield.com.

Except for historical information contained herein, this press release contains forward-looking statements, including statements regarding the timing and success of regulatory submissions for products under development and anticipated future results from clinical studies. Forward-looking statements are subject to risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. The forward-looking statements contained in this press release speak only as of the date of this press release and Endologix undertakes no obligation to update any forward-looking statements contained in this press release to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

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