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

MassDevice

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

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices

OrbusNeich

Japan OKs OrbusNeich’s Combo Plus stent

September 25, 2019 By Danielle Kirsh

OrbusNeich Medical today said it won market approval in Japan for its Combo Plus coronary stent. The Combo Plus stent is designed to address the risk of stent thrombosis associated with delayed healing in conventional drug-eluting stents. The Combo Plus DES uses endothelial progenitor cell capture technology and abluminal sirolimus drug elution delivered from a biodegradable […]

Filed Under: Drug-Device Combinations, Drug-Eluting Stents, Regulatory/Compliance, Stents Tagged With: OrbusNeich

Cardiovascular Systems touts first patients treated with Teleport microcatheter

December 26, 2018 By Sarah Faulkner

Cardiovascular Systems (NSDQ:CSII) touted today that the first patients in the U.S. were treated with the OrbusNeich Teleport microcatheter. The device, which recently won 510(k) clearance with the FDA, enables safe guidewire exchange during cardiovascular procedures. The Teleport product features a robust tip to provide access to challenging lesions, according to Cardiovascular Systems. Dr. Annapoorna Kini, […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Vascular, Wall Street Beat Tagged With: Cardiovascular Systems Inc., OrbusNeich

Cardiovascular Systems enters Chinese market through OrbusNeich deal

November 8, 2018 By Fink Densford

Cardiovascular Systems (NSDQ:CSII) said today that it successfully launched its Diamondback 360 coronary orbital atherectomy system in China as part of a distribution agreement with OrbusNeich. St. Paul, Minn.-based Cardiovascular Systems said that the first patient has already been treated with the device in Hong Kong. “Orbital Atherectomy is simple to use. It is a very controllable […]

Filed Under: Business/Financial News, Catheters, Distribution Tagged With: Cardiovascular Systems Inc., OrbusNeich

ACC ’18 Roundup: Abbott releases long-term HeartMate 3 data

March 12, 2018 By Sarah Faulkner

Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure. Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session. More […]

Pages: Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development, Structural Heart, Vascular, Wall Street Beat Tagged With: Abbott, Aetna, AliveCor, iRhythm Technologies Inc., Janssen Pharmaceuticals, Medtronic, OrbusNeich, Philips, Scripps Research Institute, Zoll Medical

Cardiovascular Systems touts OrbusNeich coronary balloon FDA nod

March 2, 2018 By Fink Densford

Cardiovascular Systems (NSDQ:CSII) said today that the FDA granted 510(k) clearance to the OrbusNeich‘s 1mm Sapphire II Pro coronary balloon. St. Paul, Minn.-based Cardiovascular Systems touted the newly cleared product as the first and only 1mm coronary balloon available in the US. “Offering the Sapphire II Pro 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is […]

Filed Under: 510(k), Cardiovascular, Catheters, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Cardiovascular Systems Inc., OrbusNeich

Cardiovascular Systems inks partnerships with OrbusNeich, Integer

January 18, 2018 By Chris Newmarker

Cardiovascular Systems (Nasdaq: CSII) announced today that it is expanding its product portfolio through new partnerships with OrbusNeich and Integer. The OrbusNeich partnership makes St. Paul, Minn.–based CSI the exclusive U.S. distributor of Hong Kong–based OrbusNeich‘s balloon products. The deal with Frisco, Texas–based Integer (NYSE: ITGR) involves Integer producing CSI-branded Zilient guidewires. Get the full story on our sister site Medical […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Contract Manufacturing, Distribution, News Well Tagged With: Cardiovascular Systems Inc., integer, OrbusNeich

TCT 2017: Medtronic & OrbusNeich evaluate shortening dual antiplatelet therapy with drug-eluting stents

November 2, 2017 By Sarah Faulkner

At this year’s Transcatheter Cardiovascular Therapeutics meeting, companies presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent. Among those companies were Medtronic (NYSE:MDT) and OrbusNeich. Here’s a look at what they found. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Pharmaceutical, Vascular, Wall Street Beat Tagged With: Medtronic, OrbusNeich

TCT 2017: OrbusNeich’s dual therapy stent non-inferior to Abbott’s Xience DES in 1-year follow-up

October 31, 2017 By Sarah Faulkner

OrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott’s (NYSE:ABT) Xience stent in patients with ischemic heart disease. The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting stent after […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Drug-Eluting Stents, Pharmaceutical, Stents, Vascular Tagged With: OrbusNeich

OrbusNeich wins FDA nod for Sapphire II Pro, NC Plus balloon dilation caths

June 6, 2017 By Fink Densford

OrbusNeich said today it won FDA 510(k) clearance for its Sapphire II Pro and Sapphire NC Plus balloon dilation catheters and launched the devices in the US. The Hong Kong-based company’s Sapphire II Pro features a sub-zero tapered tip and an ultra-low profile for entry through tight lesions, as well as a proprietary XR balloon for crossability […]

Filed Under: 510(k), Catheters, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: OrbusNeich

OrbusNeich launches Combo Plus stent

November 21, 2016 By Sarah Faulkner

OrbusNeich said today that it launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease. After the stent is implanted, the biological coating captures endothelial progenitor cells and kicks off formation of an endothelial layer. A coating of bioabsorbable polymer […]

Filed Under: Cardiovascular, Drug-Device Combinations, Drug-Eluting Stents, Vascular Tagged With: OrbusNeich

OrbusNeich expands into PAD

May 24, 2016 By Fink Densford

OrbusNeich said today it expanded its portfolio to include its Jade and Scoreflex percutaneous transluminal angioplastyballoon devices designed to treat peripheral artery disease. The balloon devices are OrbusNeich’s 1st foray into lower limb and arteriovenous fistula intervention, the Hong Kong-based company said. “Broadening our offering to include peripheral products is a natural progression for OrbusNeich. […]

Filed Under: Business/Financial News, Vascular Tagged With: OrbusNeich

  • Page 1
  • Page 2
  • Page 3
  • Page 4
  • Go to Next Page »

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
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

Copyright © 2025 · 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.

Privacy Policy