• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Consumer groups urge FDA to rescind 510(k) clearance for Aptus endostapler

Consumer groups urge FDA to rescind 510(k) clearance for Aptus endostapler

February 29, 2012 By MassDevice staff

Aptus Endosystems HeliFX

A group of consumer advocates demanded that the FDA heighten testing requirements for certain medical devices, taking exception to the agency’s 510(k) clearance of Aptus Endosystems Inc.’s HeliFX endostapling system.

In a letter to FDA commissioner Dr. Margaret Hamburg, a coalition of 12 patient safety groups expressed their concern that the de novo pathway, intended for moderate-risk products with no substantial equivalents already on the market, was inappropriately used for higher-risk products – like the HeliFX – that should have gone though the more rigorous pre-market approval process.

Although not at odds with the de novo system itself, the troup argued that the HeliFX system, categorized as a Class III device and designed to fix leaks and migration in implanted endografts, circumvented the more appropriate and stringent PMA pathway by claiming to be something it isn’t.

"FDA has responded to the Institute of Medicine’s recommendation by starting to beef up the de novo process, but instead of selecting a moderate-risk device, as the law requires, the FDA inappropriately used the de novo review process for a device that is obviously intended to save lives," Dr. Diana Zuckerman, of the National Research Center for Women & Families, one of the signers of the letter, said in prepared remarks. "To get around the law, the FDA is claiming that the product is not life-saving and therefore does not need to be tested by rigorous clinical trials and inspections, as is required for life-saving devices."

In the letter the groups ask that the FDA "provide an explanation of how these devices, which repair an aortic endograft, do not satisfy the criteria that the FDA sets for high-risk devices."

Aptus won the FDA’s OK in November 2011, making HeliFX the 1st product on the market approved to repair aortic grafts that migrate, leak or are at risk of doing either.

An endograft is a tube used to repair a bulge in the wall of the large blood vessel that carries blood away from the heart. Aptus’ HeliFX is a minimally invasive system of staples, delivered via catheter, that allows a surgeon to reach the blood vessel and staple the top edges of the endograft to the tissue to anchor it in place.

The FDA’s decision was based on data from a clinical trial of 154 patients who received a total of 810 endostaples, according to the FDA. After 1 year of follow-up with regular CT scans, there were no incidents of staple fracture and no patients experienced movement in their endografts, although 1 patient did have an endoleak.

That wasn’t enough for the consumer groups, who wrote that "the limited clinical testing of the endovascular suturing system was inadequate to prove the safety or efficacy of this implanted device for most patients, since it included only 10 women (and 144 men), no comparison control group, and only 1 year of follow-up."

The organizations asked Hamburg to rescind HeliFX’s 510(k) clearance and force the product through the PMA pathway as a life-saving device.

Aptus Endosystems did not immediately return requests for comment.

The groups involved in petition are:

  • American Medical Women’s Assn.
  • Center for Medical Consumers
  • Community Access National Network
  • Consumers Union
  • Jacobs Institute of Women’ Health
  • National Consumers League
  • National Research Center for Women & Families / Cancer Prevention & Treatment Fund
  • National Women’s Health Network
  • Our Bodies Ourselves
  • Public Citizen
  • U.S. PIRG
  • WoodyMatters

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Aptus EndoSystems Inc., Consumers Union, Endovascular

In case you missed it

  • Fusion Robotics wins FDA clearance for 3D imaging robotic targeting system
  • FDA authorizes Q-Collar to help protect athletes’ brains
  • The top 7 medtech CEO quotes on COVID-19, one year later
  • Forest Devices touts study of stroke detection tech
  • iRhythm’s revenue jumps 33% in Q4
  • Thermo Fisher completes Mesa Biotech acquisition
  • ICU Medical dips despite Street-beating Q4
  • Silk Road Medical touts results of large TCAR study
  • Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
  • 8 drug delivery innovations you need to know
  • Terumo to acquire Health Outcomes Sciences
  • Axonics acquires Contura and its Bulkamid bulking agent for $235M
  • NuVasive reports mixed Q4 results
  • Is J&J’s COVID-19 vaccine linked to tinnitus?
  • UK passes post-Brexit medical device regulation
  • Stereotaxis up on Street-beating Q4 results
  • Nevro posts Street-beating Q4 results

RSS From Medical Design & Outsourcing

  • Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
    The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers. The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers. Pfizer asked… […]
  • 8 drug delivery innovations you need to know
    The drug delivery space has seen plenty of innovation over the years and there are no signs of that slowing down any time soon. Improvements upon established technologies like insulin delivery devices and inhalers have been presented by some, while others have unlocked new ways of delivering drugs through a variety of means. Among the… […]
  • Hoffer Plastics gains MedAccred certification again
    Injection molding company Hoffer Plastics (South Elgin, Ill.) announced that it has received the MedAccred re-certification from not-for-profit medtech audit provider MedAccred. MedAccred is a supply-chain oversight program of the Performance Review Institute. It conducts critical-process audits for its member OEMs to ensure their suppliers adhere to global regulations and requirements, and helps reduce the number… […]
  • UK passes post-Brexit medical device regulation
    The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by… […]
  • Integrated Polymer Solutions acquires IRP Group
    Integrated Polymer Solutions (“IPS”), a portfolio company of Arcline Investment Management, announced this week that it has acquired IRP Group. IRP designs and manufacturers elastomeric sealing components from its facilities in Southern California. Founded in 1999, the company is focused on the Class I and II medical device market as well as the aerospace &… […]
  • Interpower debuts plugs in new colors
    Interpower announced that its NEMA 5-20 hospital-grade plugs for use in North America now come in molded colors of clear, black or gray on 10-foot lengths of flexible cord. These molded plugs complement the company’s NEMA 5-20 hand-wired hospital-grade plugs. The North American 18A hospital-grade power cord on 14 AWG SJT cable and North American… […]
  • Portescap motors gain certification
    Portescap announced that its slotless brushless DC motors for respirators have received ISO 13485:2016 certification. Expanding on ISO 9001, this standard contains specific requirements for parts traceability and risk management activities throughout the design and development stages. It also requires process and software validations at defined intervals. Independent risk management and quality compliance firm DNV… […]
  • Instron launches update to product testing system
    Materials testing equipment and software developer Instron announced the launch of the Torsion Add-On 3.0 for universal testing systems. Recently redesigned to take advantage of the latest functionality offered by the new Instron 6800 series, this system offers a simpler, safer, and more intuitive user experience, according to Norwood, Mass.-based Instron. Instron introduced the Torsion… […]
  • Abiomed CEO Michael Minogue appointed as AdvaMed chairperson
    Medtech trade group AdvaMed today said it has appointed Abiomed (NSDQ:ABMD) president and CEO Michael Minogue as chairperson of the AdvaMed board of directors, effective immediately. Minogue will serve as chairperson of the trade association’s board of directors for two years. He has been a member of the board since 2007 and a member of the board… […]
  • Credit card-sized pump could enable ‘power clothing’ to help patients with mobility
    Robotic clothing that is entirely soft and could help people to move more easily is a step closer to reality thanks to the development of a new flexible and lightweight power system for soft robotics. The discovery by a team at the University of Bristol (UK) could pave the way for wearable assist devices for… […]
  • ACSYS Lasertechnik debuts quick-change laser system
    ACSYS Lasertechnik (Lenexa, Kan.) recently announced the development of its patent-pending, ultra-short pulse,  quick-change laser system for marking, engraving and cutting for medical device applications. The system uses a galvanometer scanner equipped with either f-theta marking optics or a laser cutting head to provide interchangeable flexibility and precision. When in marking mode, the system can… […]

Leave a Reply Cancel reply

You must be logged in to post a comment.

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS