JenaValve Trilogy Delivery Catheter recall: Jenavalve Technology Inc., Class II (FDA event 99697)
https://recallregister.com/fda/ii/99697/
https://recallregister.com/fda/ii/99697/
November 7, 2026 at 7:01 PM
JenaValve Trilogy Delivery Catheter recall: Jenavalve Technology Inc., Class II (FDA event 99697)
https://recallregister.com/fda/ii/99697/
https://recallregister.com/fda/ii/99697/
Thank you to our #ASEIRTPartner, JenaValve Technology, Inc., for funding this webinar series!
March 24, 2025 at 8:02 PM
Thank you to our #ASEIRTPartner, JenaValve Technology, Inc., for funding this webinar series!
Thank you to our #ASEIRTPartner, JenaValve Technology, Inc., for funding this webinar series!
March 5, 2025 at 9:38 PM
Thank you to our #ASEIRTPartner, JenaValve Technology, Inc., for funding this webinar series!
per Dr Caldera:
.
Dr. Treede warned us about the off label use of TAVR devices for aortic regurgitation. 15% embolization compared to 1.1% with the dedicated JenaValve
.
#tavr #tavi #cardiosky
.
Dr. Treede warned us about the off label use of TAVR devices for aortic regurgitation. 15% embolization compared to 1.1% with the dedicated JenaValve
.
#tavr #tavi #cardiosky
November 26, 2024 at 7:14 PM
per Dr Caldera:
.
Dr. Treede warned us about the off label use of TAVR devices for aortic regurgitation. 15% embolization compared to 1.1% with the dedicated JenaValve
.
#tavr #tavi #cardiosky
.
Dr. Treede warned us about the off label use of TAVR devices for aortic regurgitation. 15% embolization compared to 1.1% with the dedicated JenaValve
.
#tavr #tavi #cardiosky
La Unidad de Cardiología Intervencionista del Álvaro Cunqueiro ha sido elegida para introducir el 'Jenavalve', un nuevo dispositivo para tratar la regurgitación aórtica
El hospital de Vigo, pionero en España en emplear un nuevo implante contra la insuficiencia aórtica | enfoques.gal
La Unidad de Cardiología Intervencionista del Álvaro Cunqueiro ha sido elegida para introducir el 'Jenavalve', un nuevo dispositivo para tratar la regurgitación aórtica La Unidad de Cardiología Intervencionista del Álvaro Cunqueiro ha sido elegida para introducir el 'Jenavalve', un nuevo dispositivo para tratar la regurgitación aórtica
enfoques.gal
July 28, 2026 at 3:04 PM
La Unidad de Cardiología Intervencionista del Álvaro Cunqueiro ha sido elegida para introducir el 'Jenavalve', un nuevo dispositivo para tratar la regurgitación aórtica
The FTC Challenges Edwards Lifesciences’ $945M Acquisition of JenaValve
The FTC Challenges Edwards Lifesciences’ $945M Acquisition of JenaValve
On August 6, 2025, the Federal Trade Commission (“FTC”) filed a motion for preliminary injunction to block Edwards Lifesciences Corporation’s...
www.jdsupra.com
August 19, 2025 at 5:06 PM
The FTC Challenges Edwards Lifesciences’ $945M Acquisition of JenaValve
The FTC Goes All In on Head-To-Head Competition for Pipeline Medical Devices Merger Challenge
The FTC Goes All In on Head-To-Head Competition for Pipeline Medical Devices Merger Challenge
On August 6, the Federal Trade Commission (FTC) challenged Edwards Lifesciences Corp.'s proposed $945 million acquisition of JenaValve...
www.jdsupra.com
August 19, 2025 at 10:35 AM
The FTC Goes All In on Head-To-Head Competition for Pipeline Medical Devices Merger Challenge
ALIGN-AR Trial:
First major study focused specifically on high-risk patients with severe aortic regurgitation.
Device: JenaValve Trilogy THV
Result: >95% device success, low 30-day mortality & stroke, improved symptoms.
A game-changer for a previously untreatable group.
#ACC25
First major study focused specifically on high-risk patients with severe aortic regurgitation.
Device: JenaValve Trilogy THV
Result: >95% device success, low 30-day mortality & stroke, improved symptoms.
A game-changer for a previously untreatable group.
#ACC25
April 13, 2025 at 8:36 PM
ALIGN-AR Trial:
First major study focused specifically on high-risk patients with severe aortic regurgitation.
Device: JenaValve Trilogy THV
Result: >95% device success, low 30-day mortality & stroke, improved symptoms.
A game-changer for a previously untreatable group.
#ACC25
First major study focused specifically on high-risk patients with severe aortic regurgitation.
Device: JenaValve Trilogy THV
Result: >95% device success, low 30-day mortality & stroke, improved symptoms.
A game-changer for a previously untreatable group.
#ACC25
Feed: "Becker’s ASC"
By: Cameron Cortigiano on Thursday, March 19, 2026
By: Cameron Cortigiano on Thursday, March 19, 2026
FDA approves 1st transcatheter heart valve system for ssAR
JenaValve Technology has received premarket approval from the FDA for its Trilogy THV System. The system is now the first transcatheter device in the U.S. with a dedicated indication for patients with symptomatic, severe aortic regurgitation, according to a March 18 news release from the company. The FDA approval is supported by a study that […]
www.beckersasc.com
March 20, 2026 at 5:53 PM
Feed: "Becker’s ASC"
By: Cameron Cortigiano on Thursday, March 19, 2026
By: Cameron Cortigiano on Thursday, March 19, 2026
Feed: "Medical Device Network"
By: Ross Law on Wednesday, March 18, 2026
By: Ross Law on Wednesday, March 18, 2026
JenaValve strikes US market first with approval in TAVR-AR indication
The FDA PMA for JenaValve's Trilogy device for TAVR-AR comes months after a court struck down Edwards Lifesciences attempt to buy the company.
www.medicaldevice-network.com
March 19, 2026 at 7:27 PM
Feed: "Medical Device Network"
By: Ross Law on Wednesday, March 18, 2026
By: Ross Law on Wednesday, March 18, 2026
Feed: "MedTech Dive - Latest News"
By: Susan Kelly on Monday, January 12, 2026
By: Susan Kelly on Monday, January 12, 2026
Edwards calls off JenaValve buyout after court halts deal
Edwards terminated the deal after the Federal Trade Commission moved to block the acquisition due to anticompetitive concerns.
www.medtechdive.com
January 12, 2026 at 4:47 PM
Feed: "MedTech Dive - Latest News"
By: Susan Kelly on Monday, January 12, 2026
By: Susan Kelly on Monday, January 12, 2026
Feed: "Medical Device Network"
By: GlobalData Healthcare on Friday, August 15, 2025
By: GlobalData Healthcare on Friday, August 15, 2025
FTC to block Edwards Lifesciences’ acquisition of JenaValve due to competitive concerns
JenaValve is obtaining FDA approval for the first transcatheter aortic valve designed to address aortic regurgitation.
www.medicaldevice-network.com
August 16, 2025 at 3:35 AM
Feed: "Medical Device Network"
By: GlobalData Healthcare on Friday, August 15, 2025
By: GlobalData Healthcare on Friday, August 15, 2025
Feed: "Business-News-Today.com"
By: Pallavi Madhiraju on Tuesday, August 12, 2025
By: Pallavi Madhiraju on Tuesday, August 12, 2025
FTC challenges Edwards Lifesciences’ bid for JenaValve over heart-valve competition
Learn why the FTC is suing to block Edwards Lifesciences’ acquisition of JenaValve and what the case means for heart-device innovation and competition.
business-news-today.com
August 12, 2025 at 12:54 PM
Feed: "Business-News-Today.com"
By: Pallavi Madhiraju on Tuesday, August 12, 2025
By: Pallavi Madhiraju on Tuesday, August 12, 2025
Feed: "Becker's Hospital Review | Healthcare News & Analysis"
By: Alexandra Murphy on Thursday, August 7, 2025
By: Alexandra Murphy on Thursday, August 7, 2025
FTC sues to block Edward LifeSciences’ devicemaker acquisition
The Federal Trade Commission filed a lawsuit to prevent Edward LifeSciences from acquiring JenaValve Technology, arguing the deal would stifle innovation in treatments for aortic regurgitation, a serious heart condition in which blood leaks in the heart chamber, Bloomberg reported Aug. 6. The complaint, filed in U.S. District Court for the District of Columbia, alleges […]
www.beckershospitalreview.com
August 7, 2025 at 10:42 PM
Feed: "Becker's Hospital Review | Healthcare News & Analysis"
By: Alexandra Murphy on Thursday, August 7, 2025
By: Alexandra Murphy on Thursday, August 7, 2025
Feed: "MedTech Dive - Latest News"
By: Susan Kelly on Wednesday, August 6, 2025
By: Susan Kelly on Wednesday, August 6, 2025
FTC moves to block Edwards’ JenaValve acquisition
Edwards Lifesciences and JenaValve said they remain committed to completing the deal and would defend the case in court.
www.medtechdive.com
August 6, 2025 at 9:33 PM
Feed: "MedTech Dive - Latest News"
By: Susan Kelly on Wednesday, August 6, 2025
By: Susan Kelly on Wednesday, August 6, 2025
The FTC sued to block Edwards Lifesciences from acquiring medical device maker Jenavalve. The acquisition would give Edwards control of the only two medical devices currently undergoing FDA clinical trials to treat a serious heart condition known as aortic regurgitation.
August 6, 2025 at 5:16 PM
The FTC sued to block Edwards Lifesciences from acquiring medical device maker Jenavalve. The acquisition would give Edwards control of the only two medical devices currently undergoing FDA clinical trials to treat a serious heart condition known as aortic regurgitation.
JenaValve’s Trilogy THV Evaluated in Expanded Cohort of ALIGN-AR Pivotal Trial
citoday.com/news/JenaVal...
citoday.com/news/JenaVal...
JenaValve’s Trilogy THV Evaluated in Expanded Cohort of ALIGN-AR Pivotal Trial - Cardiac Interventions Today
April 7, 2025—JenaValve Technology, Inc. recently announced results from the expanded cohort of 500 patients in the ALIGN-AR pivotal trial. ALIG
citoday.com
April 8, 2025 at 12:55 PM
JenaValve’s Trilogy THV Evaluated in Expanded Cohort of ALIGN-AR Pivotal Trial
citoday.com/news/JenaVal...
citoday.com/news/JenaVal...
A D.C. federal judge issued an order on Friday preventing Edwards Lifesciences from moving ahead with its planned $945 million deal for JenaValve Technology while the FTC challenges the merger.
Judge Blocks Edwards' $945M Heart Valve Deal - Law360
A D.C. federal judge issued an order on Friday preventing Edwards Lifesciences Corp. from moving ahead with its planned $945 million deal for JenaValve Technology Inc., torpedoing the merger challenged by the Federal Trade Commission.
www.law360.com
January 12, 2026 at 1:35 PM
A D.C. federal judge issued an order on Friday preventing Edwards Lifesciences from moving ahead with its planned $945 million deal for JenaValve Technology while the FTC challenges the merger.
BREAKING: A D.C. federal judge issued an order on Friday preventing Edwards Lifesciences from moving ahead with its planned $945 million deal for JenaValve Technology while the Federal Trade Commission challenges the merger. www.law360.com/artic...
January 9, 2026 at 10:00 PM
BREAKING: A D.C. federal judge issued an order on Friday preventing Edwards Lifesciences from moving ahead with its planned $945 million deal for JenaValve Technology while the Federal Trade Commission challenges the merger. www.law360.com/artic...
A D.C. federal judge refused to bar a pair of outside doctors and consultants from vouching for Edwards Lifesciences ' planned JenaValve Technology acquisition, preferring to let the FTC contest their testimony in cross-examination. www.law360.com/artic...
November 14, 2025 at 2:00 AM
A D.C. federal judge refused to bar a pair of outside doctors and consultants from vouching for Edwards Lifesciences ' planned JenaValve Technology acquisition, preferring to let the FTC contest their testimony in cross-examination. www.law360.com/artic...
Edwards Lifesciences urged a D.C. federal court to reject the FTC's bid to put its planned $945 million acquisition of JenaValve on hold, saying the deal will increase innovation and save the lives of thousands of people with a form of heart valve disease. www.law360.com/artic...
November 7, 2025 at 3:45 AM
Edwards Lifesciences urged a D.C. federal court to reject the FTC's bid to put its planned $945 million acquisition of JenaValve on hold, saying the deal will increase innovation and save the lives of thousands of people with a form of heart valve disease. www.law360.com/artic...