Percutaneous aortic valve replacement

Medtronic Evolut TAVR System Demonstrates Excellent Outcomes in Study of Low-Risk Patients with Bicuspid Aortic Stenosis

Retrieved on: 
Sunday, March 29, 2020
Circulatory system, Medical specialties, Medicine, Cardiac surgery, Heart valves, Percutaneous aortic valve replacement, Cardiology, Aortic valve, Aortic stenosis, Bicuspid aortic valve, Heart valve, Valve replacement

DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced late-breaking clinical data from the Low Risk Bicuspid Study assessing the use of the Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risk.

Key Points: 
  • DUBLIN, March 29, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced late-breaking clinical data from the Low Risk Bicuspid Study assessing the use of the Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risk.
  • We feel confident that these primary early outcomes provide additional evidence that the Evolut TAVR platform is a suitable treatment option for patients with bicuspid valves who have previously been left out of TAVR trials.
  • The Evolut TAVR system is not currently approved in any geography for use in patients with bicuspid aortic valve stenosis at low surgical risk.
  • The Evolut TAVR platform including the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. Bicuspid valve patients at intermediate risk or higher may be candidates for TAVR in the U.S.

TriGUARD 3™ Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Retrieved on: 
Tuesday, March 10, 2020
Heart, Percutaneous aortic valve replacement, Anatomy, Heart valve, Medicine, Aortic valve, Cardiac surgery, John G. Webb, Cardiology

TAMPA, Fla., March 10, 2020 /PRNewswire/ -- Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3 Cerebral Embolic Protection (CEP) Device.

Key Points: 
  • TAMPA, Fla., March 10, 2020 /PRNewswire/ -- Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3 Cerebral Embolic Protection (CEP) Device.
  • The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures.
  • The TriGUARD 3 CEP device is the only CE Marked product designed to cover and protect all three major cerebral aortic arch vessels.
  • Keystone Heart recently completed the REFLECT Trial (a pivotal randomized trial of the TriGUARD 3 CEP device).

TriGUARD 3™ Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Retrieved on: 
Tuesday, March 10, 2020
Heart, Percutaneous aortic valve replacement, Anatomy, Aortic valve, Heart valve, Medicine, Cardiac surgery, John G. Webb, Cardiology

TAMPA, Florida, March 10, 2020 /PRNewswire/ -- Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3 Cerebral Embolic Protection (CEP) Device.

Key Points: 
  • TAMPA, Florida, March 10, 2020 /PRNewswire/ -- Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3 Cerebral Embolic Protection (CEP) Device.
  • The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures.
  • The TriGUARD 3 CEP device is the only CE Marked product designed to cover and protect all three major cerebral aortic arch vessels.
  • Keystone Heart recently completed the REFLECT Trial (a pivotal randomized trial of the TriGUARD 3 CEP device).

Cardiovalve Receives ‘Breakthrough Device Designation’ for Its Transcatheter Tricuspid Valve Replacement System

Retrieved on: 
Thursday, February 20, 2020
Medical specialties, Medicine, Circulatory system, Cardiac surgery, Valvular heart disease, Heart valves, Mitral valve, Valve replacement, Heart valve, Tricuspid insufficiency, John G. Webb, Percutaneous aortic valve replacement

The Cardiovalve System also has been granted Breakthrough Device Designation status by the FDA.

Key Points: 
  • The Cardiovalve System also has been granted Breakthrough Device Designation status by the FDA.
  • Amir Gross, CEO of Cardiovalve, added: "We are excited about the FDAs recognition of the potential clinical benefit of the Transcatheter Tricuspid Valve Replacement System.
  • Cardiovalve has developed an innovative transfemoral valve replacement system where the valve mimics current surgical replacement solutions that can fit both mitral and tricuspid indications, covering 90% of the patient population with three approved valve sizes, using the same delivery system.
  • The flagship Cardiovalve transcatheter system is a novel valve replacement device designed for transfemoral use to replace the native Mitral/Tricuspid regurgitating valve by using a transfemoral procedure.

Cardiovalve Receives ‘Breakthrough Device Designation’ for Its Transcatheter Tricuspid Valve Replacement System

Retrieved on: 
Thursday, February 20, 2020
Cardiology, Biotechnology, General Health, Health, FDA, Medical devices, Clinical trials, Other Health, Medical specialties, Medicine, Circulatory system, Cardiac surgery, Valvular heart disease, Heart valves, Mitral valve, Valve replacement, Heart valve, Tricuspid insufficiency, John G. Webb, Percutaneous aortic valve replacement

The Cardiovalve System also has been granted Breakthrough Device Designation status by the FDA.

Key Points: 
  • The Cardiovalve System also has been granted Breakthrough Device Designation status by the FDA.
  • Amir Gross, CEO of Cardiovalve, added: "We are excited about the FDAs recognition of the potential clinical benefit of the Transcatheter Tricuspid Valve Replacement System.
  • Cardiovalve has developed an innovative transfemoral valve replacement system where the valve mimics current surgical replacement solutions that can fit both mitral and tricuspid indications, covering 90% of the patient population with three approved valve sizes, using the same delivery system.
  • The flagship Cardiovalve transcatheter system is a novel valve replacement device designed for transfemoral use to replace the native Mitral/Tricuspid regurgitating valve by using a transfemoral procedure.

Global Heart Valve Repair and Replacement Devices Market 2019-2023 | Evolving Opportunities with Abbott and Boston Scientific Corporation | Technavio

Retrieved on: 
Thursday, February 6, 2020
Health, Medical devices, Cardiology, Cardiac surgery, Medicine, Medical specialties, Clinical medicine, Valve replacement, Heart valve repair, Percutaneous aortic valve replacement, Aortic valve

View the full release here: https://www.businesswire.com/news/home/20200206005605/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20200206005605/en/
    Technavio has announced its latest market research report titled global heart valve repair and replacement devices market 2019-2023 (Graphic: Business Wire)
    Read the 127-page report with TOC on Heart Valve Repair and Replacement Devices Market Analysis Report by Product (Heart valve replacement devices and Heart valve repair devices), Surgery (Minimally invasive surgeries, Transcatheter surgeries, and Open surgeries), Geography (Asia, Europe, North America, and ROW), and the Segment Forecasts, 2019-2023.
  • In addition, technological advances are anticipated to boost the growth of the heart valve repair and replacement devices market.
  • Technavio has segmented the heart valve repair and replacement devices market based on the product, surgery, and region.
  • Heart Valve Repair and Replacement Devices Product Outlook (Revenue, USD Billion, 2019 - 2023)
    Heart Valve Repair and Replacement Devices Surgery Outlook (Revenue, USD Billion, 2019 - 2023)

JenaValve Technology Closes $50 Million Financing

Retrieved on: 
Wednesday, February 5, 2020
Medical devices, Health, Surgery, Pharmaceutical, Cardiology, Biotechnology, Medicine, Medical specialties, Heart, Cardiac surgery, Aortic valve, Percutaneous aortic valve replacement, Valve replacement, Bain Capital, Heart valve, Gimv, HDE, Aorta, the JenaValve Transfemoral TAVR System, Bain Capital Life Sciences, JenaValve

JenaValve Technology, Inc. , developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences .

Key Points: 
  • JenaValve Technology, Inc. , developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease, announces that it has raised $50 million in an equity financing led by Bain Capital Life Sciences .
  • Additional participants in the financing included existing investors Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.
  • The Company also announces the appointment of Andrew Hack, MD, PhD, Managing Director of Bain Capital, to the JenaValve Board of Directors.
  • This financing supports our ongoing clinical program and plans to file for U.S. Humanitarian Device Exemption (HDE) approval in the second half of 2020.

Emboline Completes $5 Million Bridge Round of Financing

Retrieved on: 
Thursday, January 30, 2020
Medical devices, Health, Surgery, Other Health, Clinical trials, Cardiology, Medicine, Cardiac surgery, Medical specialties, Clinical medicine, Cardiology, Percutaneous aortic valve replacement, Aortic valve, Valve replacement

Emboline, Inc. , developer of embolic protection technology for brain and body during transcatheter aortic valve replacement (TAVR), today announced the closing of a $5 million bridge round of financing from a number of existing and new investors.

Key Points: 
  • Emboline, Inc. , developer of embolic protection technology for brain and body during transcatheter aortic valve replacement (TAVR), today announced the closing of a $5 million bridge round of financing from a number of existing and new investors.
  • This financing is ahead of an expected Series C financing later this year.
  • This round of financing will provide working capital for us to make significant regulatory and clinical progress as we finalize our forthcoming Series C round.
  • 2019 was a pivotal year for Emboline as we completed our SafePass 2 study with outstanding results, said Emboline founder and chairman Amir Belson, MD.

Teleflex Receives FDA Clearance for Wattson™ Temporary Pacing Guidewire

Retrieved on: 
Wednesday, January 22, 2020
Medicine, Cardiac surgery, Medical specialties, Clinical medicine, Percutaneous aortic valve replacement, Transvenous pacing, Valve replacement, BAV, Catheter, Aortic valve, Aortic valvuloplasty

WAYNE, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the WattsonTM Temporary Pacing Guidewire the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV).

Key Points: 
  • WAYNE, Pa., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration for the WattsonTM Temporary Pacing Guidewire the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV).
  • This innovative device offers clinicians a 0.035 pigtailed guidewire that supports valve delivery and allows simultaneous intraventricular bipolar pacing during TAVR or BAV procedures.
  • WattsonTM Temporary Pacing Guidewire is designed to simplify and shorten TAVR procedures by eliminating the need for routine use of central venous access and transvenous temporary pacing catheters.
  • The WattsonTM Temporary Pacing Guidewire offers:
    A multiple electrode configuration and bipolar design, engineered to inspire confidence in capture during rapid pacing
    FDA 510(k) clearance is another important milestone for the WattsonTM Temporary Pacing Guidewire and for our Interventional business, said Matt Anderson, President and General Manager of the Interventional business unit of Teleflex.

JenaValve Transcatheter Aortic Valve Replacement (TAVR) System Designated by FDA as Breakthrough Device

Retrieved on: 
Thursday, January 9, 2020
Health, FDA, Medical devices, Surgery, Clinical trials, Cardiology, Biotechnology, Medicine, Medical specialties, Cardiac surgery, Clinical medicine, Percutaneous aortic valve replacement, Aortic valve, Valve replacement, Heart valve, Aorta, Pericardial heart valves, Edwards Lifesciences, JenaValve Transfemoral TAVR System, JenaValve

JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA).
  • Under the program, the FDA will provide JenaValve with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
  • The JenaValve Pericardial TAVR System is an investigational device, and is not available for sale in the United States or internationally.
  • JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K., and Munich, Germany, develops and manufactures transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease.