• 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 » TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump

TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump

October 14, 2015 By Brad Perriello

TCT 2015St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer.

The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects passed the primary safety endpoint of a composite of major adverse events and the primary efficacy endpoint of freedom from hemodynamic compromise during percutaneous coronary intervention.

The study results, released today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco, also showed low complication rates, including no incidence of device-related cardiac death, myocardial infarction or intraprocedural hypotension. St. Jude acquired the HeartMate PHP when it paid $3 billion for Thoratec last week.

“We are excited to share the results of Shield I, which support the safety and performance of the HeartMate PHP device,” principal investigator Dr. Dariusz Dudek, of the University Hospital in Krakow, said in prepared remarks. “The data from Shield I demonstrate that the HeartMate PHP device is a highly promising technology that should be considered for high-risk patients, such as those with advanced heart failure or who may be at risk of cardiogenic shock, undergoing PCI procedures.”

“Globally, there’s a significant opportunity for patients to benefit from cardiovascular pumps that address an otherwise unmet clinical need for complete circulatory support during high-risk PCI procedures,” added St. Jude chief medical officer Dr. Mark Carlson. “The Shield I study results demonstrate the consistent and reliable circulatory support offered by the HeartMate PHP cardiac assist device, which was designed as a novel advancement to traditional catheter-based support devices.”

Last month Thoratec launched a trial pitting the HeartMate PHP against Abiomed‘s (NSDQ:ABMD) competing Impella 2.5 percutaneous heart pump as it seeks U.S. approval for the device.

Here’s a look at other news coming out of TCT 2015:

 Stents: MiCell releases 4-year data on MiStent SES

 Stents: Elixir Medical live-streams DESolve Cx procedure

 Stents: Intracoronary brachytherapy cuts in-stent restenosis

 Stents: Tryton Medical’s side-branch device meets primary endpoint in pivotal trial

 Stents: 3-year data confirms long-term performance for Stentys self-apposing device

Filed Under: Cardiovascular, Catheters, Clinical Trials Tagged With: Elixir Medical Corp., Micell Technologies Inc., Stentys, stjudemedical, TCT 2015, Tryton Medical Inc.

In case you missed it

  • Obalon Therapeutics’ stock skyrockets after announcing ReShape Lifesciences merger
  • EmblemHealth to provide coverage for Senseonics’ Eversense CGM
  • Abbott’s MitraClip receives boost as CMS expands coverage for TMVR
  • Haemonetics to acquire Cardiva
  • DePuy Synthes lands FDA clearance for Velys robotic knee system
  • New COVID-19 variants could diminish vaccine efficacy
  • DJO acquires Trilliant Surgical and its foot and ankle implants
  • GE Healthcare reportedly lays off 140 in Wisconsin
  • Learn What Quality Trends to Watch for in 2021
  • HHS could make permanent pandemic-related exemptions for some devices
  • Medtechs can’t set digital strategies aside – DTW Podcast
  • NIH increases PhysIQ contract to $6.6M
  • Senseonics announces $50M from stock offering
  • Protolabs to acquire 3D Hubs for up to $330M
  • TransEnterix receives CE Mark for AI for its robotic surgery system
  • Hillrom to buy Bardy Diagnostics for $375M
  • Philips aquires Capsule Technologies and its medical device data tech

RSS From Medical Design & Outsourcing

  • XL Precision Technologies plans UK, U.S. expansions
    XL Precision Technologies (XL-PT) has announced a major capital investment to expand facilities in the first quarter of 2021. At the primary manufacturing site in Stockton-on-Tees (UK), XL-PT has signed the lease to the adjacent building, which will add 17,400 ft2 of floor space to the existing capacity. Occupancy is expected within three months. XL-PT… […]
  • Researchers tout biomaterials that can be ‘fine-tuned’ for medtech
    Researchers in the UK and U.S. are touting a new thermoplastic biomaterial capable of “fine-tuning” for use in soft tissue repair or bioelectronics. According to a news release, the material, which is a type of polyester, has been developed by a team at the University of Birmingham (UK) and Duke University (U.S.) for use in… […]
  • HHS could make permanent pandemic-related exemptions for some devices
    HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process. In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided… […]
  • Medtechs can’t set digital strategies aside – DTW Podcast
    Digital connectivity no longer belongs in the final slides of a medtech company’s pitch deck. In the latest DeviceTalks Weekly podcast, three leaders pushing for connected medical devices explain the need to incorporate data collection and monitoring functionality in new devices: Scott Huennekens, who advanced the “digital surgery” strategy when he helped launch Verb Surgical,… […]
  • Protolabs to acquire 3D Hubs for up to $330M
    Protolabs (NYSE: PRLB) today announced it plans to acquire Amsterdam-based 3D Hubs, an online manufacturing platform that provides engineers with on-demand access to a global network of approximately 240 manufacturing partners. The transaction creates a comprehensive digital manufacturing offer for custom parts, expanding Protolabs’ breadth of capabilities as well as adding a broader offering of pricing and… […]
  • These medtech stocks performed the best in 2020
    While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while… […]
  • Covestro tests plastics against high-strength hospital disinfectants
    Covestro announced that it recently teamed with disinfectant manufacturer Metrex to test five different Covestro polycarbonate materials against three of Metrex’s products, which are widely used throughout the healthcare industry. As is customary for rapidly assessing the compatibility of plastics to disinfectants, test specimens were pre-strained and underwent several wipe-and-dry cycles with Metrex disinfectants to… […]
  • Integer expands N.Y. battery plant
    Integer announced today that it recently broke ground on an expansion of its Alden, N.Y., facility to accommodate new equipment that will substantially increase the plant’s production capacity for rechargeable Xcellion lithium-ion batteries. The project kicked off in mid-December 2020 and will add both production equipment and a build-out of Integer’s existing facility. The company… […]
  • Diversified Plastics adds high-efficiency vertical presses
    Diversified Plastics (DPI) announced that it recently installed six all-electric vertical injection molding presses. These presses will join DPI’s existing assemblage of vertical presses and provide increased production capacity to meet growing demand from medical device and other original equipment manufacturers (OEMs). DPI uses vertical presses for over-molding and insert-molding, capabilities often required for medical… […]
  • Traco Power expands power supply line for portable medical equipment
    Traco Power announced that it has expanded its TPP 450 high-density 3×5 power supply series. The series now offers Protection Class II models (TPP 450BA-M Open-Frame Models and TPP 450B-M Enclosed with Fan Models), designed for non-stationary requirements where connection to ground is not possible. Key approvals on the original series remain on the expanded… […]
  • Reflow Medical launches low-profile reinforced support catheters
    Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters. The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. They come in 0.014 in. and 0.018 in. sizes and can be combined with… […]

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