Heart valve

Foldax Receives FDA Approval to Initiate Clinical Study of Biopolymer Mitral Heart Valve

Retrieved on: 
Lundi, décembre 14, 2020

Foldax , Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria biopolymer mitral surgical heart valve.

Key Points: 
  • Foldax , Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval for the company to initiate a U.S. clinical study of its Tria biopolymer mitral surgical heart valve.
  • The company anticipates the first use of its mitral valve in a human will take place in the coming weeks.
  • The mitral valve is the second of three Tria biopolymer heart valve products in the Foldax portfolio, and addresses a large unmet clinical need based on the prevalence of rheumatic fever worldwide.
  • The first of the companys products an aortic surgical heart valve is currently enrolling a U.S. clinical study as a result of FDA approval of an expanded study last October.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Boston Scientific Corporation (BSX) on Behalf of Investors

Retrieved on: 
Lundi, décembre 7, 2020

Law Offices of Howard G. Smith announces an investigation on behalf of Boston Scientific Corporation (Boston Scientific or the Company) (NYSE: BSX ) investors concerning the Companys possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Boston Scientific Corporation (Boston Scientific or the Company) (NYSE: BSX ) investors concerning the Companys possible violations of federal securities laws.
  • On November 17, 2020, Boston Scientific announced a worldwide recall of all unused inventory of the LOTUS Edge Aortic Valve System, a transcatheter aortic valve replacement product which had been approved by the U.S. Food and Drug Administration (FDA) in April 2019.
  • On this news, Boston Scientific's stock price fell $3.00 per share, or approximately 8%, to close at $35.03 per share on November 17, 2020, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Structural Heart Medical Device Patent Portfolio Is For Sale

Retrieved on: 
Lundi, décembre 7, 2020

Hilco Streambank brought this patent portfolio to market in 2019 as part of the Receivership of LC Therapeutics, Inc., and facilitated a sale to a creditor of the company.

Key Points: 
  • Hilco Streambank brought this patent portfolio to market in 2019 as part of the Receivership of LC Therapeutics, Inc., and facilitated a sale to a creditor of the company.
  • These assets are once again available for sale, along with a newly issued AF patent.
  • The MR patents protect technology surrounding artificial chords of predetermined lengths used to repair the mitral valve chordae during MR surgical procedures.
  • Parties interested in the assets or learning more about the sale process should CLICK HERE or contact Hilco Streambank directly using the contact information provided below.

Study Finds TMVR Procedural Efficiency with use of the VersaCross® RF Transseptal Solution

Retrieved on: 
Mardi, décembre 1, 2020

The VersaCross platform is the world's first, exchangeless solution for access-to-delivery of left heart therapy devices.

Key Points: 
  • The VersaCross platform is the world's first, exchangeless solution for access-to-delivery of left heart therapy devices.
  • The publication, titled "Initial Clinical Experience with VersaCross Transseptal System for Transcatheter Mitral Valve Repair" was published in Catheterization and Cardiovascular Interventions, in November 2020.
  • Initial findings concluded procedural efficiency, citing 3.3 minutes to gain transseptal access and a subsequent 3.8 minutes to achieve MitraClip Guide delivery, with a 100% success rate.
  • Using the VersaCross RF Transseptal Solution from femoral access; based on 3.3 min for TSP and 3.8 min for subsequent MitraClip guide exchange.

Anteris Technologies to Present at Credit Suisse Structural Heart Forum on November 23, 2020

Retrieved on: 
Jeudi, novembre 19, 2020

BRISBANE, Australia and EAGAN, Minn., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Anteris Technologies Ltd (ASX:AVR) (Anteris or the Company), a structural heart company advancing its novel DurAVRvalve for aortic repair and replacement, today announced its participation in a symposium hosted by Credit Suisse, featuring important technologies addressing major structural heart indications.

Key Points: 
  • BRISBANE, Australia and EAGAN, Minn., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Anteris Technologies Ltd (ASX:AVR) (Anteris or the Company), a structural heart company advancing its novel DurAVRvalve for aortic repair and replacement, today announced its participation in a symposium hosted by Credit Suisse, featuring important technologies addressing major structural heart indications.
  • The forum, entitled Credit Suisse Virtual Structural Heart Sessions, will feature new companies in the structural heart disease space who are developing disruptive solutions for large market opportunities such as Transcatheter Aortic ValveReplacement (TAVR), and Surgical Aortic Valve Replacement (SAVR) procedures, and others.
  • The three-hour event will take place virtually on November 23rd at 10:00AM ET, and will be moderated by Matt Miksic, Senior Analyst at Credit Suisse.
  • Anteris Technologies Ltd is a structural heart company delivering clinically superior and durable solutions through better science and better design.

United Kingdom Prosthetic Heart Valves Market Outlook to 2025 - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves

Retrieved on: 
Mercredi, novembre 18, 2020

"United Kingdom Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the United Kingdom Prosthetic Heart Valves market.

Key Points: 
  • "United Kingdom Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the United Kingdom Prosthetic Heart Valves market.
  • The databook report provides value (USD), volume (units) and average prices (USD) within market segments - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves.
  • - 2019 company share and distribution share data for Prosthetic Heart Valves Market.
  • - Global corporate-level profiles of key companies operating within the United Kingdom Prosthetic Heart Valves Market.

Italy Prosthetic Heart Valves Market Outlook to 2025 - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves

Retrieved on: 
Mercredi, novembre 18, 2020

"Italy Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the Italy Prosthetic Heart Valves market.

Key Points: 
  • "Italy Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the Italy Prosthetic Heart Valves market.
  • The databook report provides value (USD), volume (units) and average prices (USD) within market segments - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves.
  • - 2019 company share and distribution share data for Prosthetic Heart Valves Market.
  • - Global corporate-level profiles of key companies operating within the Italy Prosthetic Heart Valves Market.

Germany Prosthetic Heart Valves Market Outlook to 2025 - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves

Retrieved on: 
Mercredi, novembre 18, 2020

"Germany Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the Germany Prosthetic Heart Valves market.

Key Points: 
  • "Germany Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the Germany Prosthetic Heart Valves market.
  • The databook report provides value (USD), volume (units) and average prices (USD) within market segments - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves.
  • - 2019 company share and distribution share data for Prosthetic Heart Valves Market.
  • - Global corporate-level profiles of key companies operating within the Germany Prosthetic Heart Valves Market.

France Prosthetic Heart Valves Market Outlook to 2025 - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves

Retrieved on: 
Mercredi, novembre 18, 2020

"France Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the France Prosthetic Heart Valves market.

Key Points: 
  • "France Prosthetic Heart Valves Market Outlook to 2025" is a comprehensive databook report, covering key market data on the France Prosthetic Heart Valves market.
  • The databook report provides value (USD), volume (units) and average prices (USD) within market segments - Mechanical Heart Valves, Tissue Heart Valves and Transcatheter Heart Valves.
  • - 2019 company share and distribution share data for Prosthetic Heart Valves Market.
  • - Global corporate-level profiles of key companies operating within the France Prosthetic Heart Valves Market.

Global Aortic Valve Market Research Report 2020: Valve Type (Tissue/Biological, Mechanical), Suture Type (Sutured, Sutureless), Procedure (Open Surgery, Minimally Invasive Surgery) - ResearchAndMarkets.com

Retrieved on: 
Vendredi, novembre 13, 2020

The "Aortic Valve Market Research Report: By Valve Type (Tissue/Biological, Mechanical), Suture Type (Sutured, Sutureless), Procedure (Open Surgery, Minimally Invasive Surgery), End User (Hospitals, Ambulatory Surgery Centers) - Global Industry Analysis and Growth Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Aortic Valve Market Research Report: By Valve Type (Tissue/Biological, Mechanical), Suture Type (Sutured, Sutureless), Procedure (Open Surgery, Minimally Invasive Surgery), End User (Hospitals, Ambulatory Surgery Centers) - Global Industry Analysis and Growth Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • When procedure is taken into consideration, the aortic valve market is divided into open surgery and minimally invasive surgery (MIS), between which, the MIS division held the major value share of the market in 2019.
  • Some of the common treatments recommended for aortic stenosis are transcatheter aortic valve treatment and surgical valve replacement.
  • Companies operating in the aortic valve market are focusing widely on business mergers, strategic partnerships, product launches, and trial and approvals for remaining competitive in the domain.