MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Endologix recall of abdominal stent graft system is Class I

Endologix recall of abdominal stent graft system is Class I

By

Endologix Ovation iX abdominal stent graft
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 become compromised during pressurization with liquid polymer.

Endologix isn’t asking health providers to return the 5,403 devices involved in the recall but is instead making doctors aware that they should carefully consider the risk of polymer leaks during implantation against the risks associated with alternative treatment options. The company is updating device labeling accordingly.

FDA earlier this year approved Endologix’s Alto abdominal stent graft system.

“Endologix is committed to replacing Ovation iX with the recently FDA-approved Alto graft by the end of October 2020,” Endologix CEO John Onopchenko said in a news release yesterday.

“Alto is technically easier to implant and has been designed to improve acute outcomes, while retaining the unique durability of the Ovation platform,” Onopchenko said. “Importantly, Alto incorporates design and manufacturing changes that are intended to eliminate the areas of material weakness associated with polymer leaks. We believe Alto should meaningfully reduce the incidence of polymer leaks. We look forward to receiving approval for Alto in the EU, where the graft is in the final stages of CE Marking review.”

 

 

 

 

In case you missed it

RSS From Medical Design & Outsourcing

  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]
  • New implant design prevents scar tissue without drugs, MIT says
    Mechanically inflating and deflating an implantable device for 10 minutes a day prevents immune cells from building the scar tissue that has been a major obstacle for artificial pancreas researchers. That’s according to new findings from a team of MIT engineers who built mechanical deflection into a two-chambered, soft polyurethane device tested on mice. By… […]
  • Blue Spark’s TempTraq catches fevers faster. Fever prediction is next.
    Blue Spark Technologies developed the first wireless continuous temperature monitor patch, TempTraq, to enable faster fever detection than standard manual readings every four hours. Westlake, Ohio-based Blue Spark is now looking at fever prediction rather than just detecting them. The R&D team is working on developing an AI neural network model built on the company’s… […]
  • Harvard researchers plan to sell at-home, PCR-grade COVID testing system
    The Harvard University researchers who developed an ultrasensitive, PCR-grade nucleic acid detection technology plan to commercialize it as a portable COVID-19 test. Harvard Medical School professor Peng Yin, who also leads the Wyss Institute for Biologically Inspired Engineering’s Molecular Robotics Initiative, founded 3EO Health to sell the device. “In order to optimize the value of… […]
  • FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
    The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities. The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage… […]
  • AdvaMed defends EtO facilities on EPA’s cancer risk list
    The Advanced Medical Technology Association (AdvaMed) today reacted to the EPA’s listing of commercial sterilization facilities causing elevated risks of cancer with a defense of the facilities and a call for more research. AdvaMed CEO and President Scott Whitaker said all of the listed facilities are in compliance with regulations and warned against closures. “The… […]
  • EPA flags high-cancer-risk EtO sterilization facilities across the country
    The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities. EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only… […]
  • New method of cardiac ablation used in first in-human trial for ventricular tachycardia
    A new cardiac ablation technique for patients with ventricular tachycardia (VT) has been used in its first in-human multicenter trial involving Mayo Clinic. The new process — needle ablation using in-catheter, heated, saline-enhanced, radio frequency (SERF) energy — creates lesion scars inside the heart muscle where life-threatening arrhythmias cause VT, Mayo Clinic said. Injecting heated saline… […]
  • AdvaMed pushes CMS for proposed TCET pathway rule this year
    The Advanced Medical Technology Association (AdvaMed) is asking the Centers for Medicare & Medicaid Services (CMS) to move fast on a new way to guarantee reimbursement for new medtech innovations. CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access… […]