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 …

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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.

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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…

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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…

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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.

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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…

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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…

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FDA committee to examine safety of endovascular stent grafts

AFX Endovascular AAA system [Image courtesy of Endologix]FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies.

Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially higher-than-expected risk of blood leakage called Type III endoleaks. Endologix has found itself having to vigorously defend itself against studies claiming a problem.

The FDA is presently advising that anyone with any Endologix AFX endovascular graft (AFX with Strata, AFX with Duraply, or AFX2) visits a doctor at least once a year to get checked for leaks.

Another Endologix product — the Ovation iX abdominal stent graft system — was the subject of a Class I recall last year including five deaths, though Endologix clarified that two of the five deaths took place follo…

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The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

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The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

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Endologix wins CE Mark for Alto abdominal stent graft system

Endologix (NSDQ:ELGX) this week said it received CE mark approval for its Alto Abdominal Stent Graft System.

“We are very excited to receive a CE Mark for the Alto system, that has been achieved through a strong partnership and collaboration with our European notified body, NSAI,” chief medical officer Matt Thompson said in a news release.

The Alto Abdominal Stent Graft System is an Ovation system for polymer endovascular aneurysm repair. It first received FDA approval in March this year.

“Alto offers a highly differentiated endovascular treatment option to AAA patients and includes design features that we believe will enhance ease-of-use, improve acute outcomes and preserve the long-term durability associated with patient-specific anatomically adaptive sealing,” CEO John Onopchenko said.

“We believe Alto, with its ultra-low profile and 7 mm aortic neck length indication, will provide patients and physicians with an endograft capable of treating t…

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MedTech 100 roundup: Medtech stocks bump along

Medical device company stocks appear to be in a holding pattern as investors wait for new earnings reports.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — bumped along last week. It closed at 84.39, about where it had been at the start of the week. The Dow Jones Industrial Average and S&P 500 performed similarly.

The Index as of the end of last week was up 35.8% from 62.13 on March 23 — its lowest point so far during the pandemic. It’s still down –8.6% from its pre-pandemic-crash high point of 92.32 on Feb. 19.

The MedTech 100 Index started today with an uptick but then ended about where it started — even as tech stocks powered the DJIA up 1%.

Investors, for now, appear to have already absorbed worries about the surge in new COVID-19 cases in the South and elsewhere in the United States. Expect more clarity from the markets when the next round of quarterly earnings comes out later…

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