• 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
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » TCT 2010 roundup: Abbott keeps after Boston Scientific’s Taxus

TCT 2010 roundup: Abbott keeps after Boston Scientific’s Taxus

September 24, 2010 By MassDevice staff

TCT2010, stent wars logo

Abbott (NYSE:ABT) kept up the pressure on Boston Scientific Corp. (NYSE:BSX) at a high-profile cardiology conference, releasing data from a pair of studies it says show that its Xience V drug-eluting stent is better than Boston Scientific’s competing Taxus.

Two-year data from the head-to-head trials of the paclitaxel-eluting Taxus against the everolimus-eluting Xience stent showed that more patients treated with BSX’s stent developed late-stent thrombosis. The data were presented in Washington, D.C., at the annual Transcatheter Cardiovascular Therapeutics conference.

In one trial, the Spirit IV study, nearly three-quarters of the patients in both arms were still on dual antiplatelet therapy after two years. But in the other trial, the Compare study, only 15 percent of the Taxus arm and 11 percent of the Xience arm were receiving that therapy after the two-year mark. The Compare results showed no statistically significant difference between the two arms after a year, when 70 percent of all subjects were still on the DAP therapy. But after two years, the data show, there was a 77 percent reduction in late stent thrombosis in the Xience arm.

"Xience is superior, and clinicians should be aware of the long-term risk with the Taxus stent," Dr. Dean Kereiakes of Ohio Heart Health Center in Cincinnati told MedPage Today. Physicians should be aware that patients implanted with the Taxus stent should stay on the DAP therapy for more than a year, Kereiakes added.

"I think the polymer and the thicker struts of the first generation [Taxus] stents set up an inflammatory reaction and that may be what is happening," he said.

Dr. Antonio Colombo of New York Presbyterian Hospital called the low thrombosis rates in the Spirit IV trial "almost unrealistically low," according to MedPage Today.

Abbott wasn’t the only company looking to make waves at the conference. Medical device industry players large and small are busy hawking the results of clinical trials and touting new products — or new versions of older products. Here’s a look at some of the initial releases from the conference. TCT 2010 is slated to run through Sept. 25.

  • Abiomed
    • Uspella registry results: Abiomed Inc. (NSDQ:ABMD) reported the latest results from its Uspella registry of 352 patients treating with its Impella 2.5 cardiac assist device. Patients treated for prophylactic revascularization showed a 17 percent improvement of left ventricular ejection fraction; a 61 percent reduction in patients classified as having New York Heart Assn. Class 4 heart failure; a 25 percent reduction in the target population for implantable cardiac defibrillators; and low rates of mortality (3.9 percent) and major adverse cardiac events (8.2 percent).

      Patients who received Impella support before an angioplasty procedure showed a nearly 60 percent reduction in mortality. Ninety percent of survivors recovered "native cardiac function" and were discharged with their own hearts.
      Read more

  • OrbusNeich
    • Six-month data from the Perfect Stent trial: This 120-patient trial compared patients treated with OrbusNeich’s Genous bio-engineered R stent and B. Braun Inc.’s paclitaxel-coated balloon versus patients treated with the Genous stent alone. Six months after the procedures, in-stent late loss was 0.34mm for subjects treated with both devices, compared with 0.88mm for the group treated with the stent alone. No stent thrombosis was reported for either arm of the study; both groups received three months of DAP therapy. Rates of target lesion revascularization and MACE were lower in the investigational group compared to the control group.

      “We are very encouraged by the good clinical and safety outcomes seen in patients treated with a combination of a paclitaxel-coated balloon and pro-healing technologies with only three months of dual antiplatelet therapy,” said principal investigator Dr. Jochen Woehrle of the University of Ulm, Germany. “This study supports the company’s development efforts with the Combo Stent.”
      Read more

  • Biosensors International Group Ltd.
    • Eight-month Care II study results: Patients implanted with the Sparrow drug-eluting stent, designed to be the smallest-profile stent in the world, showed average in-stent late loss of 0.29mm, compared with 0.86mm for patients treated with the Sparrow bare-metal stent and 0.99mm in patients treated with Medtronic Inc.’s (NYSE:MDT) MicroDriver BMS. Rates MACE were 6.25 percen for the Sparrow DES, 14.3 percent for the Sparrow BMS and 26.7 percent for the MicroDriver.

      "The CARE II eight-month results demonstrate the efficacy and safety of the Sparrow drug-eluting stent system in small coronary arteries, and suggest that its guidewire-like delivery mechanism and less traumatic stent expansion characteristic may improve outcomes in small vessels," said principal investigator Dr. Alexandre Abizaid of the Instituto Dante Pazzanese de Cardiologia in Sao Paulo, Brazil.
      Read more

    • Three-year results from the Leaders trial: This trial, comparing the biolimus A9-eluting BioMatrix Flex stent with Johnson & Johnson (NYSE:JNJ) subsidiary Cordis Corp.’s Cypher Select stent, showed similar MACE rates after three years. Patients at risk for heart attack (ST elevation myocardial infarction), however, showed a 9.6 percent MACE rate in the BioMatrix arm and a 20.7 percdent rate in the Cypher arm.

      "These further follow-up results from LEADERS confirm that the BioMatrix Flex stent continues to be safe and effective three years after implantation in an all-comers population, reflecting patients treated in routine clinical practice," said Patrick Serruys of the Erasmus Medical Center in the Netherlands.
      Read more

  • PLC Systems Inc.
    • Mythos RenalGuard trial update: This 157-patient trial examined the use of the RenalGuard system to prevent contrast-induced nephropathy in angioplasty patients with chronic kidney disease. Patients at high risk for renal failure who were treated with the system while undergoing imaging procedures developed CIN at a 69 percent lower rate than those treated beforehand with overnight hydration.
      Read more

Filed Under: Business/Financial News, Drug-Eluting Stents, News Well Tagged With: Abbott, Boston Scientific, Clinical Trials

In case you missed it

  • Technical Brief – “Understanding the Extensive OEM Benefits of Total Linear Motion Solutions.”
  • Exactech launches total hip arthroplasty system
  • Lensar announces first patients treated with Ally adaptive cataract treatment
  • HeartBeam submits heart attack diagnostic platform for FDA 510(k) clearance
  • GE Healthcare leads AliveCor Series F funding for ECG tech
  • New FDA ruling may lower costs for over-the-counter hearing aids
  • Data supports Sight Sciences’ Omni surgical system for glaucoma
  • Integra founder Richard Caruso has died
  • Moximed raises $40M for implantable shock absorber for knee osteoarthritis
  • Philips names Roy Jakobs as CEO amid ventilator, CPAP recalls
  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Dyad Medical wins FDA clearance for cardiac imaging platform Echo:Prio
  • Outset Medical wins national VA contract
  • Inspire Medical Systems appoints former Zimmer Biomet exec as VP of investor relations
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Acutus Medical ticks up on revenue beat, missed EPS in Q2 results
  • ResMed expects steady growth over the next year

RSS From Medical Design & Outsourcing

  • What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic
    Dr. Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics. It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic (NYSE: MDT) — was in a meeting… […]
  • Senators seek post-market FDA study of pulse oximeters and skin color
    Democratic U.S. senators are prodding the FDA to launch a post-market study of pulse oximeters due to unreliable performance for patients with dark skin. Pulse oximeters estimate blood oxygen levels (SpO2) and pulse rates in patients using infrared light — usually on a fingertip — at home or in clinical settings. Blood oxygenation is one… […]
  • TE Connectivity opens global medical device prototyping center in Ireland
    TE Connectivity (NYSE:TEL) today announced it opened its global Propelus Prototype Center for medical devices in Galway, Ireland. The $5 million rapid prototyping center was built into its existing manufacturing site in Galway and directly connects TE engineers with customers to reduce development time and increase speed to market for lifesaving and life-improving medical devices. Propelus… […]
  • Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye
    Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized. St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020. The minimally invasive device gives neurosurgeons deep… […]
  • What’s next for Jennifer Fried after leaving Explorer Surgical?
    Explorer Surgical co-founder Jennifer Fried has resigned from the company after selling it to Global Healthcare Exchange in October. Fried announced her departure last week on LinkedIn, saying she’s preparing for her next professional chapter. “It’s bittersweet — I’m so proud of everything our team has built and accomplished,” Fried wrote. “The time has flown… […]
  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]
  • FDA’s breakthrough medical device designations tally nears 700
    Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases. According to recent metrics published by FDA, the agency has issued a total of… […]
  • Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing
    Lifecore Biomedical parent company Landec Corp. (Nasdaq:LNDC) plans to take the subsidiary’s name, leadership and headquarters as its own and sell off food businesses to focus on contract development and manufacturing. Santa Maria, California-based Landec said it will rename itself as Lifecore Biomedical “in the near future” and change its Nasdaq ticker to LFCR. Landec… […]
  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

August 12, 2022
DTW – Medtronic’s Mauri brings years of patient care to top clinical, regulatory, scientific post
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
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks 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