Endologix Archives - Medical Design Sourcing

Endologix picks former Medtronic leader as new chief commercial officer

Endologix announced today that it appointed Mike Mathias as its new chief commercial officer (CCO), effective immediately.

Mathias brings 30 years of experience leading commercial organizations within the cardiovascular area. He most recently served as VP of commercial operations at Limflow. He held that role from 2022 until Inari Medical acquired the chronic limb-threatening ischemia (CLTI) treatment maker last year.

At Endologix, his role includes overseeing commercial operations for the artery disease treatment developer.

“Joining Endologix at such a critical juncture is an honor,” Mathias said in a news release. “I am excited to apply my experience to innovate and join the leadership team of a company that stands at the forefront of interventional vascular therapies. Together, we will work to enhance our commercial strategy, ensuring success for our commercial teams and the organization as a whole.”

Before LimFlow, Math…

The best medtech innovations of 2023

Recognize this medtech innovation? It was one of the nominees for the Galien Foundation’s 2023 Prix Galien USA Awards. [Image courtesy of Boston Scientific]

The Galien Foundation’s 2023 Prix Galien USA Awards recognized a first-of-its-kind cancer diagnostic and other medtech innovations.

Announced last week, the Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

“The outstanding quality of the submissions is a testament to the promising future of the life sciences industries,” said former Johnson & Johnson CEO and Chair Alex Gorsky — one of the awards jurors — in a news release announcing the nominees.

Last year’s winners included Cala Health, Abbott, Edwards Lifesciences and Roche. (See all of 2022’s nominees here, including many that were nominated again in 2023.)

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Endologix completes first procedures using Detour system to kick off U.S. launch

Percutaneous transmural arterial bypass (PTAB) using the Detour system. [Image courtesy of Endologix]Endologix announced today that the first patients underwent a procedure using its Detour system since it received FDA approval.

The FDA approved Detour for use in percutaneous transmural arterial bypass (PTAB) to treat peripheral arterial disease (PAD) last month. This initial procedure marks the official start of the company’s targeted market release of Detour in the U.S.

PTAB with Detour enables a disruptive, novel approach to treating PAD. It enables physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein. This restores blood flow to the leg, effectively treating patients with long lesions (20cm-46cm in length), Endologix says. It also treats those who already underwent failed endovascular procedures or those who represent suboptimal open surgical bypass candidates.

For the rollout of the Detour…

2-year data supports Endologix Detour system for treating PAD

Percutaneous transmural arterial bypass (PTAB) using the Detour system. [Image courtesy of Endologix]About a week after garnering FDA approval, Endologix announced positive 24-month data for its Detour system for treating PAD.

Irvine, California picked up premarket approval on June 7 for its Detour system to treat long, complex superficial femoropopliteal lesions.

The DETOUR2 study evaluated the system’s performance in percutaneous transmural arterial bypass (PTAB). This approach aims to treat complex peripheral arterial disease (PAD) by percutaneously bypassing lesions in the superficial femoral artery. It uses stents routed through the femoral vein to restore blood flow to the leg.

Endologix’s EndoCross device and Torus stent grafts comprise the Detour system.

Principal investigator Dr. Sean Lyden presented two-year results from the study at the 2023 Annual Meeting of the Society of Vascular Surgery. Lyden serves as chair of the Departm…

FDA approves Endologix’s Detour femoropopliteal lesions treatment device

Endologix recently announced it received FDA approval for its Detour system to treat long, complex superficial femoropopliteal lesions.

The company said the Detour system offers a new approach to treating complex peripheral artery disease to allow physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg.

“We are delighted to receive FDA approval of the Detour System,” President and CEO Matt Thompson said in a news release. “PTAB therapy represents a significant step forward for patients with complex PAD, they have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the U.S. through a targeted market release in the coming weeks.”

Endologix suggests that the approach…

Endologix wins CE mark for abdominal aortic aneurysm system

The AFX2 system. [Image from Endologix]Endologix announced today that it received CE mark approval for its AFX2 endovascular abdominal aortic aneurysm (AAA) system.

Irvine, California-based Endologix designed the AFX2 system with unique sealing technology that preserves native bifurcation to provide durable outcomes and personalized repair for AAA patients.

“CE Mark certification under the new [EU MDR] requirements is a high-bar and we are proud of this significant company achievement,” Elisa Hebb, Endologix EVP of medical, clinical, regulatory affairs and quality, said in a news release. “Meeting the rigor of the new framework is an important milestone for our AFX2 System.”

Endologix introduced the currently marketed AFX2 system in 2016 and had its comparative performance studied in the Leopard randomized clinical trail that evaluated AFX2 and its AFX predecessor device to other commercially available endografts.

Five-year results …

Endologix reports positive results from percutaneous bypass trial

Endologix announced today that 12-month results from a trial of its Detour system demonstrated a low rate of complications.

Irvine, California-based Endologix’s Detour 2 FDA investigational device exemption (IDE) study was designed to evaluate the safety and effectiveness of the Detour system for percutaneous bypass in the treatment of long-segment femoropopliteal disease.

Get the full story at our sister site, Medical Tubing & Extrusion.

Matthew Thompson promoted to corner office at Endologix

[Image courtesy of Endologix]Dr. Matthew Thompson, who has served as chief medical officer at Endologix since 2016, has been promoted to CEO of the vascular disease treatments company.

Richard Mott, who has been serving as interim CEO, will return to his role as executive chair of the company’s board of directors, Endologix announced November 10.

On top of his CMO duties managing business development, medical affairs, regulatory, clinical, and R&D departments, Thompson led the April 2021 acquisition and integration of PQ Bypass.

“Matt embodies the fusion of the entrepreneurial vision and subject matter expertise that we need to successfully accelerate Endologix as a leader in the development and commercialization of the most innovative devices for the treatment of vascular disease,” Mott said in a news release.

Endologix in 2020 filed for Chapter 11 bankruptcy protection. It agreed at the same time to be purchased by its largest…

Endologix wins FDA breakthrough nod for aneurysm sealing system

[Image from Endologix]Endologix announced today that the FDA granted breakthrough device designation for its Chimney endovascular aneurysm sealing system (Chevas).

Irvine, Calif.-based Endologix designed its Chevas system as an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy that combines the Nellix 3.5 endograft with parallel visceral stents to treat patients with juxtarenal, pararenal and suprarenal AAA, according to a news release.

The company is currently evaluating the Chevas system through the Chevas One investigational device exemption (IDE) clinical study, set to enroll approximately 120 patients across up to 50 clinical sites around the world.

Dr. Francis Caputo (Cleveland Clinic Foundation), Dr. William Jordan (Emory University School of Medicine), Dr. Joseph Lombardi (Cooper University Health Care) and Dr. William Quinones-Baldrich (UCLA) are the national principal investigators for the study.

The study’s…

Endologix launches Alto abdominal stent graft in Canada

Endologix (NSDQ:ELGX) today said it launched its Alto abdominal stent graft in Canada following its recent Health Canada approval.

The Alto abdominal stent graft system is a polymer-based therapy for abdominal aortic aneurysm (AAA) patients. It uses a low-profile delivery system with a conformable sealing ring that molds in-situ to the patient’s specific aortic neck anatomy.

Get the full story on our sister site, Medical Tubing + Extrusion.

DTW Podcast: How is Zimmer Biomet waging the ortho data war? Do medical devices carry physics-based biases?

This week’s DeviceTalks Weekly Podcast guests

In this week’s DeviceTalks Weekly Podcast, Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics.

Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of Zimmer’s ZB edge suite of digital and robotics technologies.

In a separate interview, we talk with Achuta Kadambi, assistant professor at the UCLA Samueli School of Engineering, about a column he contributed to Science suggesting physics may be causing medical devices to perform at varying levels in people of different races.

Kadambi explains his own work in the field and suggests how medical device developers may want to move forward in the future.

See our initial report in Medical Design and Outsourcing here.

Chris New…

Endologix acquires PQ Bypass

Endologix today announced that it has completed its acquisition of PQ Bypass for an undisclosed amount.

PQ Bypass makes the Detour platform that is designed for percutaneous femoral-popliteal bypass — providing a large lumen, endograft bypass to treat abdominal aortic aneurysm. FDA has designated Detour as a breakthrough device.

The Detour System has the company’s Torus stent graft and the PQ Crossing Device. It is currently being studied in a U.S. and European clinical trial.

“The acquisition of PQ Bypass is a seminal moment in Endologix’s history, building upon our leadership in the treatment of abdominal aortic aneurysm to champion disruptive technologies for the treatment of vascular disease,” Endologix CEO Richard Mott said in a news release. “We intend to actively pursue new and innovative vascular technologies that are clinically relevant to surgeons, hospitals and patients, with a commitment to world-class medical education, clinical resea…