• 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 & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » HeartWare pauses MVAD trial

HeartWare pauses MVAD trial

September 9, 2015 By Brad Perriello

HeartWare MVAD

UPDATED Sept. 10, 2015, with details on MVAD trial pause, expanded field action and Valtech acquisition.

HeartWare International (NSDQ:HTWR) today said it’s pausing enrollment in a clinical trial of its next-generation MVAD heart pump while it looks to fix an issue with the manufacturing process for the left ventricular assist device’s controller.

Framingham, Mass.-based HeartWare said none of the MVADs in the study are involved in the controller manufacturing issue, which does not affect the performance of the pump.

The prospective, non-randomized, single-arm study, launched in July, is slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at 6 months. Eleven patients are enrolled in the trial, CEO Doug Godshall told analysts at the Wells Fargo healthcare conference in Boston.

The trial pause pushes back the expected timeline on the MVAD pump by a month or 2, Godshall said.

The problem involves the way a circuit board is fastened inside the controller and does not require a design change. HeartWare expects to have an upgrade of the manufacturing process to improve the fastening technique complete by late September or early October, he said.

"It’s going to take probably 8 to 10 weeks to now have controller supply back online, so we’re going to take a pause on enrollment, probably until November it looks like, while we upgrade our manufacturing process on the controllers," Godshall said.

"It’s just a process change," he said. "We’re not making any fundamental design changes."

The delay shouldn’t affect the expected timing on a U.S. trial for the MVAD, which is slated for the end of this year or early next year, Godshall said.

HeartWare also discovered software bugs that will require an FDA-approved upgrade, he said.

"As we anticipated, we found, we’ve seen some software bugs that would require a regulatory approval, but that’s not a gating item, we will roll out a software probably end of this year, beginning of next year," Godshall said. "The work is going on in parallel. We have already written the code, we are testing the code and so when we move ahead in the U.S., we will have this enhanced, I guess, assembly integrity and we’ll have the new code without the bug."

Battery upgrade means expanded field action

After a new battery screening protocol greatly improved device longevity, HeartWare switched to a new battery supplier in the U.S., Godshall told Wells Fargo analyst Larry Biegelsen during the conference, noting that batteries are the company’s "largest-volume complaint product."

"We enhanced the screening of the batteries and had a dramatic improvement in performance," he explained. "This new supplier is clearly giving us a better-quality component than what we were getting before."

That means the expansion of an ongoing field action to replace the older, screened batteries, he said. The FDA approved the new batteries in June, Godshall said.

"We’re actually going to later this year, beginning next year, expand a prior field action and replace what’s left of older batteries albeit they were screened and performing well. The new ones are just that much better," he told Biegelsen. "This is an expansion of an old action because it’s sort of continuing just a larger serial number range.

HeartWare said it expects to take a $7 million to $9 million charge during the 3rd quarter as it looks to fix problems flagged in an FDA warning letter last year. The federal safety watchdog cited violations in design and software validation as well as complaint management and documentation, according to the FDA notice. The warning cites in particular the potential mismanagement of at least 27 complaints about HeartWare’s products, including 2 reported deaths and 4 serious injuries.

"Feeding frenzy" drove Valtech buy

The pending acquisition of mitral valve replacement maker Valtech, which pushed HTWR shares down -21% after it was announced last week, was HeartWare’s only shot at the red-hot mitral valve market, Godshall said.

"There was a feeding frenzy starting to develop around Valtech. We agreed with them that we would put in a 2nd investment earlier this year that would buy us an exclusivity period that expired mid-September. It was quite clear from the communications we were getting from the company that they were having to fend off interest from others. It was also quite clear from the company that they are an R&D powerhouse that doesn’t really want to build a commercial organization," he said. "Frankly if we couldn’t do Valtech, we weren’t going to do mitral because we believe we need the ability to repair surgically and repair interventionally and we believe we need a portfolio."

Interest in the mitral space was fueled by a pair of recent acquisitions, with Edwards Lifesciences (NYSE:EW) last month closing the $400 million buyout of CardiAQ Valve Technologies and Medtronic (NYSE:MDT) agreeing to pony up as much as $458 million for Twelve Inc.

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Structural Heart Tagged With: HeartWare International Inc.

In case you missed it

  • Entegris opens Life Sciences Technology Center in Massachusetts
  • Glucose monitor maker Know Labs expands leadership team
  • inHeart wins FDA clearance for 3D cardiac modeling software
  • How Glytec is advancing insulin management in the hospital
  • Anumana wins FDA breakthrough nod for AI algorithm that detects pulmonary hypertension
  • FDA clears RapidAI’s pulmonary embolism triage platform
  • Report: Dexcom in talks to acquire Insulet
  • Henry Schein investors push back on executive pay
  • Alcon to pay $60M to acquire Kala Pharmaceuticals’ dry eye treatment
  • Creo Medical inks collaboration agreement with Intuitive
  • MedTrace Pharma moves forward on 15 O-water imaging tech
  • HistoSonics, GE Healthcare agree to integrate ultrasound into sonic beam liver therapy
  • Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children
  • Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
  • FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths
  • Boston Scientific’s Acurate Neo2 valve performs well in studies
  • MicroTransponder reports first commercial implantation of its stroke rehab neurostim system

RSS From Medical Design & Outsourcing

  • Varta presents microbattery product portfolio at Computex 2022
    Varta will present its broad product portfolio of microbatteries, which make a wide range of future-proof applications possible, at Computex in Taipei starting today. Varta’s microbattery product portfolio ranges from rechargeable lithium-ion button cells to nickel metal hydride button cells, primary silver oxide cells, primary lithium button cells and cylindrical lithium batteries to hydrogen gas… […]
  • Entegris opens Life Sciences Technology Center in Massachusetts
    Entegris (Nasdaq:ENTG) announced today that it opened a new Life Sciences Technology Center in Billerica, Massachusetts. The new Life Sciences Technology Center was built to offer life sciences customers the opportunity to leverage Entegris’ cold-chain supply expertise to optimize processes, reduce costs and increase speed to market. Get the full story at our sister site,… […]
  • MedAcuity hires SVP of business development
    Medtech software development firm MedAcuity today said it has hired Simon Johnson as SVP of business development. Westford, Massachusetts-based MedAcuity said Johnson previously built the client partner team and managed strategic clients at digital consultancy Mobiquity. He also served as SVP of client services at GreenPages Technologies, responsible for driving services revenue growth leading to… […]
  • Henry Schein investors push back on executive pay
    Nearly half of Henry Schein (Nasdaq:HSIC) shareholders who voted at this month’s annual meeting voted against the company’s pay packages for top executives, according to a new SEC filing. About 48.5% of voting shareholders voted against the company’s executive pay plan in what’s known as the Say-on-Pay vote, according to vote results of the May… […]
  • Creo Medical inks collaboration agreement with Intuitive
    Creo Medical Group (LON: CREO) announced today that it has signed a multi-year collaboration agreement with Intuitive to make certain Creo surgical technologies compatible with the surgical robotic giant’s systems. The London exchange reacted by sending CREO shares up more than 4% to 100 pence apiece by the close of trading today. As of midday… […]
  • MedTrace Pharma moves forward on 15 O-water imaging tech
    MedTrace Pharma announced the first person scanned in its Rapid-Water-Flow Phase 3 clinical trial, further testing its tech to bring 15 O-water to imaging. The first subject scan took place at Aarhus University Hospital in Denmark, using 15 O-water produced, dosed and injected through MedTrace’s P3 automated delivery system. The clinical trial aims to evaluate… […]
  • Zimmer Biomet narrowly avoids shareholder rebuke on executive pay
    An unusually large share of Zimmer Biomet (NYSE:ZBH) investors voted against the orthopedics company’s pay packages for top executives at the annual shareholder meeting. About 54% of voting shareholders supported the pay packages of the company’s five top-paid executives at the May 13 meeting, according to results filed with the SEC yesterday. In 2021, nearly 93%… […]
  • BD, Mitsubishi Gas Chemical partner on better materials for plastic syringes
    BD (NYSE:BDX) announced that it partnered with Mitsubishi Gas Chemical Company on applying new technology to pre-fillable syringes. MGC develops the Oxycapt technology designed to integrate the best of plastic and glass for plastic syringes. BD and Tokyo-based MGC will work together to apply Oxycapt technology to the next generation of pre-fillable syringes (PFS) for advanced… […]
  • Ambu replaces CEO with new leadership
    Ambu today said it has hired board member Britt Meelby Jensen to replace CEO Juan Jose Gonzalez, effective tomorrow. “Since Juan Jose Gonzalez joined as CEO in 2019, Ambu has made good progress and achieved important milestones on the strategic transformation into the world’s largest single-use endoscopy company,” Ambu Chair Jørgen Jensen said in a… […]
  • AdvaMed joins Biden’s Joint Supply Chain Resilience Working Group
    AdvaMed executive Abby Pratt has joined the executive committee for the Biden administration’s Joint Supply Chain Resilience Working Group, the medtech industry association said today. The working group’s members from government and industry will assist with implementation of the National Strategy for a Resilient Public Health Supply Chain. Pratt oversees supply chain issues as SVP… […]
  • Toray develops new stretchable film for medical devices
    Toray Industries has a new stretchable film based on its proprietary polymer Reactis technology, with potential applications that include robotics and biological and industrial sensors. Tokyo-based Toray said it shipped samples to customers and plans research and development efforts to commercialize the new grade of film. “Recent years have increased the potential for developing stretchable… […]

Primary Sidebar

DeviceTalks Weekly

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

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.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World

Device Talks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · 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