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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…

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.

Next >>

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…

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…

Endologix files for bankruptcy, will go private

Endologix (NSDQ:ELGX) announced today that it has filed for Chapter 11 bankruptcy protection and simultaneously agreed to be purchased by its largest creditor.

That creditor, Deerfield Partners, will take the Irvine, Calif.-based abdominal aortic aneurysm (AAA) stent graft developer private. The bankruptcy filing and sale “provide the best path to address the financial challenges resulting from COVID-19 and the related delays in elective medical procedures and to realize the full benefits of operational enhancements made over the past two years,” the company said in a statement.

Under the terms of the proposed plan of financial reorganization, Endologix will eliminate approximately $180 million of debt from its balance sheet on a net basis, including approximately $130 million of debt currently held by Deerfield that will convert to equity in the reorganized company. Endologix also expects to gain access to $110.8 million of new financing through th…

Endologix recall of abdominal stent graft system is Class I

Endologix’s Ovation iX abdominal stent graft [Image courtesy of FDA]

Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system.

The FDA today gave the recall a Class I designation — its most serious level.

Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were five deaths — though Endologix clarified that two of the five deaths took place following complications after a polymer leak.

The Ovation iX system uses polymer-based technology to seal off blood from flowing into an aneurysm and to help secure the device in place. The company in a previous August 2018 safety update warned of leaks taking place due to incorrect device use, but the company now says the problem was material weakness adjacent to the polymer fill channel that may be…