• 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 » TCT 2019: Boston Scientific slides on Acurate Neo TMVR trial miss

TCT 2019: Boston Scientific slides on Acurate Neo TMVR trial miss

September 30, 2019 By Brad Perriello

TCT 2019The Acurate Neo replacement heart valve being developed by Boston Scientific (NYSE:BSX) failed to show non-inferiority in a head-to-head comparison with the Sapien 3 valve made by Edwards Lifesciences (NYSE:EW), according to study data released at the annual Transcatheter Cardiovascular Technologies conference in San Francisco.

The 739-patient Scope I study randomized increased-risk patients to either Acurate Neo or Sapien 3 transcatheter aortic valve replacement, with a primary endpoint of non-inferiority measured by a composite of safety and efficacy at 30 days.

The Acurate Neo cohort met the endpoint in 23.7% of patients, compared with 16.5% for the Sapien 3 group, failing to show non-inferiority. The main differences were higher rates of moderate or severe paravalvular regurgitation and acute kidney injury with the Boston Scientific device, according to the Cardiovascular Research Foundation.

“It would be hard to make the clinical case, forget the regulatory case, for stating, ‘Let’s use [Acurate Neo] if it performed like this relative to another choice,’” said Dr. Ajay Kirtane, of the NewYork-Presbyterian/Columbia University Irving Medical Center, according to TCTMD.

“To me it looks a bit like déjà vu, because we’ve seen this with the earlier valves and the development over time took care of these shortcomings,” added Dr. Jeroen Bax of Holland’s Leiden University Medical Center. “I think if we understand a little bit better the potential anatomical features that are related to [the SCOPE I findings], then you can work with technological developments and move forward.”

BSX shares, which closed down -4.8% at $40.31 Sept. 27, were up slightly at $40.71 today in early trading. EW shares, which closed off -1.9% at $217.29 each last week, were up 0.7% to $218.87.

 Boston’s Lotus non-inferior to Medtronic’s CoreValve
A study comparing another Boston valve, the Lotus TAVR, with the Medtronic (NYSE:MDT) CoreValve in high/extreme-risk patients, the Lotus valve met the primary 30-day safety endpoint and was superior on the primary effectiveness endpoint at one year.

The Reprise III trial randomized 912 patients to Lotus or CoreValve at a 2:1 ratio. Three years into the five-year study, the rates of all-cause mortality or disabling stroke (32.4% for Lotus and 36.6% for CoreValve) were similar for both devices. Although the rate of disabling stroke was higher with CoreValve (5.6% for Lotus, 10.5% for CoreValve), more patients in the Lotus arm (44.2%, 29.4%) ended up needing a pacemaker.

“This three-year analysis from the Reprise study demonstrates durability of benefit after Lotus valve implantation. Patients in both cohorts showed a significant improvement in functional and health status, which were preserved over 3 years of follow-up,” according to the study’s abstract.

 Edwards’ Sapien XT beats surgery at five years
Five-year results from the Partner 2A trial of Edwards’ older Sapien XT in intermediate-risk patients showed similar rates of death and disabling stroke compared with surgical valve replacement, although one TAVR implantation technique showed poorer outcomes compared with surgery.

The 2,032-patient study randomized to either TAVR or surgery, with a two-year primary endpoint of all-cause death or disabling stroke. At five years, event rates for the primary endpoint were 47.9% for TAVR and 43.4% for the surgical cohort.

Although the transfemoral group showed no difference at five years (44.5% TAVR vs. 42.0% surgical), the transthoracic TAVR group showed a significantly higher rate of death or disabling stroke (59.3% versus 48.3%). Early improvements in functional status and quality of life held steady through five years for both arms.

“In the longest follow-up for intermediate-risk patients with severe AS, TAVR and SAVR had similar rates of death or disabling stroke,” Dr. Vinod Thourani, of the Medstar Heart & Vascular Institute, said in prepared remarks. “Therefore, TAVR should be considered as an alternative to surgery in intermediate-risk patients with severe aortic stenosis. However, in patients without acceptable transfemoral access, surgery may be the preferred alternative.”

Discussion at the conference focused on paravalvular leakage, TCTMD reported.

“When this trial was ongoing, we didn’t have an appreciation that leaving these patients with paravalvular leaks, large leaks, was actually going to be bad for them. That’s what we’ve learned actually from the Partner trials, that leaving them with a lot of leaks is a bad thing,” Dr. Dharam Kumbhani, of the UT Southwestern Medical Center in Dallas, told the website. Newer valves have much lower rates of paravalvular leak, Kumbhani added.
Read More

 Sub-study shows QoL benefits for Sapien 3
A sub-study using data from the Partner 3 trial of Edwards’ Sapien 3 valve showed higher quality-of-life scores at one year for low-risk patients.

The sub-study, using data from the 1,000-patient Partner 3 trial of Kansas City Cardiomyopathy Questionnaire scores at one year, showed mean baseline KCCQ scores of 70 on the 0-100-point scale for both TAVR and surgical patients. The benefit persisted at the six- and 12-month marks, albeit at smaller magnitude after a year.

“[E]ven in the low-risk population, there is a huge value from a patient-reported-outcomes standpoint with [TAVR],” said Dr. Suzanne Baron, of the Lahey Hospital & Medical Center in Burlington, Mass., according to TCTMD.

“[P]atient-reported outcomes are incredibly important,” Baron said. “I’ve got plenty of patients who say, ‘I don’t mind if I die, but please, I do not want a stroke because I do not want to live like that.’ … A lot of these patients want to get back to what they’re doing – they want to be able to interact with their families – and in the low-risk populations it’s even more important. A lot of these patients may still be working and caring for grandkids or elderly parents. It becomes a lot more of an issue.”
Read More

 Abbott’s Portico non-inferior to contemporary TAVRs
The Abbott (NYSE:ABT) Portico valve, which was tabled for about a year back in 2014 to 2015, showed non-inferiority in a study comparing it to a roster of contemporary TAVR devices in high- or extreme-risk patients.

The 750-patient Portico trial randomized patients 1:1 to either the Abbott valve or then-commercially available devices, including iterations of Medtronic’s CoreValve and Edwards’ Sapien. The primary safety endpoint, a composite of all-cause mortality, disabling stroke, life-threatening bleeds, acute kidney injury requiring dialysis or major vascular complications. Portico showed a 13.8% rate compared with 9.6% for the control devices. Portico met the primary effectiveness endpoint (a composite of all-cause mortality or disabling stroke at one year) at 14.9% compared with 13.4% for the control.

A sub-set of 100 patients implanted using the FlexNav delivery system also met its endpoint, major vascular complications at 30 days. The FlexNav group showed no deaths or strokes, low rates of major vascular complications (7.0%) and pacemaker implants (14.6%) and safety profile similar to the control group at 8.0% and 9.6%, respectively.
Read More

 New Mitraclip data on outcomes, cost-effectiveness
Three-year data from the Coapt trial of Abbott’s Mitraclip mitral valve repair device continued to show its benefits, both in terms of outcomes and cost-effectiveness.

The rate of death/heart failure hospitalization in patients treated with Mitraclip was 58.8%, compared with 88.1% for patients treated with guideline-directed medical therapy. And of the 58 patients who crossed over to Mitraclip, the 12-month rate was 28%.

“GDMT- only patients who crossed over and received a MitraClip experienced fewer HF hospitalizations and deaths or heart failure hospitalizations within 12 months than those who did not cross over, with rates comparable to patients originally assigned to the MitraClip,” said Dr. Michael Mack, of the Baylor Scott & White Heart Hospital in Plano, Texas, according to TCTMD. “A significant number of patients died before they had the opportunity to cross over, so there, in all likelihood, is some selection bias both in terms of survivorship and the decision on the local heart team as to having these patients crossed over.”

A separate analysis of Coapt data showed that Mitraclip is comparable to other device-based heart failure treatments in terms of cost effectiveness such as implantable cardiac defibrillators and left-ventricular assist devices.

Follow-up costs were substantially lower for Mitraclip patients, compared with GDMT patients ($26,654 vs. $38,345). But the overall cost at two years was still much higher for Mitraclip, at $73,416 compared with $38,345, due to the higher up-front cost of the initial procedure. Measured in terms of incremental cost effectiveness ratio, Mitraclip was deemed “intermediate value.”

“The cost-effectiveness of TMVr for the COAPT population is comparable to that of other commonly used technologies for the treatment of heart failure, including implantable cardiac defibrillators, and is substantially more cost-effective than the use of continuous-flow left ventricular assist devices for destination therapy,” added Dr. Suzanne Baron, of the Lahey Hospital & Medical Center in Burlington, Mass. “Together with the improved clinical outcomes in the COAPT trial, these findings suggest that TMVr is a reasonable treatment strategy for this patient population based on both clinical and economic considerations.”
Read More

    • Experience improves outcomes with Mitraclip
    • Lower valve-in-valve mortality for transseptal TMVR vs. transapical
    • Transcath tricuspid repair beats medical therapy
    • No mortality difference for BD’s Lutonix paclitaxel balloon, but ‘spooky’ signal still haunts
    • PCI still as good as CABG after five years
    • Nipro’s Infraredx touts lipid-rich plaque study
    • Intact Vascular touts one-year Tack data
    • Orchestra Biomed’s BackBeat cardiac neuromod meets trial endpoint
    • Abiomed touts cardiogenic shock study
    • Biotronik touts real-world data on Magmaris resorbable magnesium stent

Filed Under: Cardiovascular, Clinical Trials, Featured, Replacement Heart Valves, Wall Street Beat Tagged With: Boston Scientific, Edwards Lifesciences, TCT 2019

In case you missed it

  • Abbott imaging catheter recall flagged as Class I by FDA
  • Will Johnson & Johnson buy Boston Scientific?
  • Needham & Co. downgrades Medtronic, Zimmer Biomet shares
  • DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes
  • Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company
  • Zimmer Biomet adds ESG and CEO visibility to executive’s duties
  • U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health
  • ‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
  • FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
  • Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023
  • Bigfoot Biomedical adds former Insulet VP as chief commercial officer
  • Medtronic, DaVita to form new kidney care company
  • Medtronic stock down on Q4 earnings miss
  • 3M Health Care Business president is leaving this year
  • Device developer SeaStar Medical hires chief medical officer
  • AccuPulse raises $10M Series A
  • Exactech announces first U.S. surgeries with its nex-gen laser cage glenoid

RSS From Medical Design & Outsourcing

  • Download COMSOL News Special Edition Biomedical
    Get instant access to this special edition of COMSOL News where you will read user stories that showcases how simulation enables engineers, researchers, and scientists explore and analyze biomedical designs. Download Now.       The post Download COMSOL News Special Edition Biomedical appeared first on Medical Design and Outsourcing.
  • Qosina adds new tube-to-tube barb connectors
    Qosina has added 25 new tube-to-tube barb connectors to its portfolio, the OEM single-use component supplier for the medical and pharmaceutical industries said this week. Ronkonkoma, New York-based Qosina said its inventory of tube-to-tube barb connectors is available in more than 500 configurations. The connectors can fit inner tube diameters between 1/32 in and 1… […]
  • Abbott imaging catheter recall flagged as Class I by FDA
    The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The… […]
  • Zimmer Biomet adds ESG and CEO visibility to executive’s duties
    Zimmer Biomet (NYSE:ZBH) today announced additional responsibilities for Investor Relations SVP and Chief Communications Officer Keri Mattox. Mattox’s new title at the Warsaw, Indiana-based orthopedics company is chief communications and administration officer. She will be responsible for “building and executing a comprehensive strategy around Environmental, Social and Governance (ESG) initiatives and increasing CEO visibility, engagement… […]
  • ‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems
    Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance. Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29. Martha said about 75%… […]
  • 3M Health Care Business president is leaving this year
    3M Health Care Business Group President Mojdeh Poul will retire from the company on July 1, 2022. Poul joined Maplewood, Minnesota-based 3M (NYSE:MMM) in 2011 as the global business VP of critical and chronic care solutions. She later became VP and general manager of the company’s food safety business and president of numerous 3M divisions,… […]
  • Iterative Scopes announces positive data in Skout AI colonoscopy algorithm clinical trial
    Iterative Scopes this week announced positive trial data in a study of its colorectal cancer screening algorithm, Skout. Cambridge, Massachusetts-based Iterative Scopes designed Skout as a computer-aided device (CADe) that uses artificial intelligence and computer vision technology to detect suspicious tissue and provide real-time feedback for gastroenterologists performing the procedure. Get the full story on… […]
  • Device developer SeaStar Medical hires chief medical officer
    SeaStar Medical has hired Dr. Kevin Chung as chief medical officer of the medtech developer starting July 1. Denver-based SeaStar is developing a platform therapy focused on hyperinflammation of vital organs. The company’s Selective Cytopheretic Device was designated as a breakthrough device by the FDA earlier this year. SeaStar is set to go public in… […]
  • 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… […]

Primary Sidebar

DeviceTalks Weekly

May 27, 2022
Quick message - No DTW podcast, but plenty else to listen to over this weekend and next week.
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