Dual therapy stent

amg International GmbH, a Q3 Medical Devices Ltd Company, Receives European CE Mark Approval for UNITY-B™ Biodegradable Stent

Retrieved on: 
Monday, May 24, 2021

The Company announced that it has received CE Mark approval for its second fully biodegradable product, the UNITY-B balloon expandable biodegradable biliary stent (BEBS) for endoscopic use.

Key Points: 
  • The Company announced that it has received CE Mark approval for its second fully biodegradable product, the UNITY-B balloon expandable biodegradable biliary stent (BEBS) for endoscopic use.
  • The UNITY-B Biodegradable implant was developed as a complimentary biodegradable metallic stent to amg's ARCHIMEDES biodegradable pancreaticobiliary stent, which is currently available in fast, medium, and long-lasting degradation profiles.
  • ARCHIMEDES obtained CE mark approval in 2018 and was subsequently launched through a global distribution partnership with Medtronic.
  • "The CE mark approval of the UNITY-B stent represents yet another milestone for amg International and all the companies of Q3 Medical and our mission to 'Create Value By Helping People'.

OrbusNeich® Announces China Approval for COMBO® Coronary Stent

Retrieved on: 
Wednesday, September 23, 2020

HONG KONG, Sept. 23, 2020 /PRNewswire/ --OrbusNeich Medical Co. Ltd. has announced that the National Medical Products Administration (NMPA) has granted market approval for the COMBO BIO-ENGINEERED SIROLIMUS ELUTING STENT in China.

Key Points: 
  • HONG KONG, Sept. 23, 2020 /PRNewswire/ --OrbusNeich Medical Co. Ltd. has announced that the National Medical Products Administration (NMPA) has granted market approval for the COMBO BIO-ENGINEERED SIROLIMUS ELUTING STENT in China.
  • "The market approval of the COMBO Stent in the Republic of China is a strategically important success for the OrbusNeich organization as we further expand into significant territories," said David Chien, OrbusNeich's Chairman, President and CEO.
  • "We expect the approval of a unique product such as the COMBO Stent to allow OrbusNeich to strengthen our presence in China alongside our existing PTCA and PTA portfolio."
  • The ongoing randomized, multi-center RECOVERY trial [NCT02542007] comparing the COMBO Stent with the polymer-free sirolimus-eluting Nano stent (PF-SES) (Lepu Medical Technology, Beijing, China) in the treatment of patients with de novo native coronary artery lesions provided clinical data supporting the approval.

Drug Eluting Stent Market Size Worth Around US$ 4,050 Mn 2027: Acumen Research and Consulting

Retrieved on: 
Tuesday, June 2, 2020

LOS ANGELES, June 2, 2020 /PRNewswire/ -- The global drug eluting stent market size is expected to be worth of around US$ 4,050 Mn by 2027 with 7% of CAGR.

Key Points: 
  • LOS ANGELES, June 2, 2020 /PRNewswire/ -- The global drug eluting stent market size is expected to be worth of around US$ 4,050 Mn by 2027 with 7% of CAGR.
  • Increasing technological advancement and regulatory approval by major players is the major driver for the growth of the drug eluting stent market.
  • A stringent regulation for product approval is a major factor expected to restraint the growth of the drug eluting stent market.
  • Moreover, the minimally invasive DES putting system improves the expansion of the drug eluting stent market.

FDA Grants Breakthrough Device Designation to Reflow Medical’s Temporary Spur Stent System

Retrieved on: 
Thursday, January 9, 2020

Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA).
  • We are extremely grateful to the FDA for their expedited designation of the Temporary Spur Stent System as a Breakthrough Device.
  • As Reflow continues to build on clinical evidence supporting the Temporary Spur Stent System, the company looks forward to furthering development in other clinical areas, based on the Spur technology platform.
  • The Temporary Spur Stent System is an investigational device only and is not currently approved for sale.

OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent

Retrieved on: 
Wednesday, September 25, 2019

of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent.

Key Points: 
  • of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent.
  • The COMBO Plus stent clinical program now has over 9,500+ subjects included in clinical trials with the COMBO stent.
  • "The market approval of the COMBO Plus Coronary Stent in Japan is a tremendous achievement for the entire OrbusNeich organization" said David Chien, OrbusNeich Medical President and CEO.
  • "A well-coordinated global effort was required to obtain the Japan market approval of a unique product such as the COMBO Plus Coronary Stent.

OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent

Retrieved on: 
Wednesday, September 25, 2019

of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent.

Key Points: 
  • of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent.
  • The COMBO Plus stent clinical program now has over 9,500+ subjects included in clinical trials with the COMBO stent.
  • "The market approval of the COMBO Plus Coronary Stent in Japan is a tremendous achievement for the entire OrbusNeich organization" said David Chien, OrbusNeich Medical President and CEO.
  • "A well-coordinated global effort was required to obtain the Japan market approval of a unique product such as the COMBO Plus Coronary Stent.

$2.05 Billion Bio-engineered Stent Market - Global Forecast to 2027

Retrieved on: 
Friday, September 6, 2019

The bio-engineered stent market was valued at US$ 2,056.8 Mn in 2018, expected to grow at a CAGR of 7.1% during the forecast period from 2019 to 2027.

Key Points: 
  • The bio-engineered stent market was valued at US$ 2,056.8 Mn in 2018, expected to grow at a CAGR of 7.1% during the forecast period from 2019 to 2027.
  • The global bio-engineered stent market is growing effectively from 2019 to 2027 accredited to the rise in hospital admissions for heart disorders along with enhanced bioengineered technology expansion in the stent industry on a global scale.
  • For example, in September 2018, Biotronik received the U.S FDA approval for coronary stent system for the management of acute coronary artery.
  • A growing number of clinical trials for future launch by global players expected to drive the growth of the market in the near future.