TAVR

Endologix Appoints Mike Mathias as Chief Commercial Officer

Retrieved on: 
Tuesday, March 5, 2024

Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced the appointment of Mike Mathias as the company’s Chief Commercial Officer, effective immediately.

Key Points: 
  • Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced the appointment of Mike Mathias as the company’s Chief Commercial Officer, effective immediately.
  • With a distinguished 30-year career in leading commercial organizations within the cardiovascular arena, Mike brings a wealth of experience and a proven track record of success to Endologix.
  • Mike is uniquely qualified to lead our global commercial team and continue the strategic development of our commercial plans.
  • In response to his new role, Mike Mathias shared, "Joining Endologix at such a critical juncture is an honor.

EISENHOWER HEALTH EARNS NATIONAL RECOGNITION WITH HeartCARE CENTER DESIGNATION

Retrieved on: 
Wednesday, February 28, 2024

RANCHO MIRAGE, Calif., Feb. 28, 2024 /PRNewswire/ -- The American College of Cardiology has recognized Eisenhower Health for its demonstrated commitment to comprehensive, high-quality culture and cardiovascular care. Eisenhower Health was awarded the HeartCARE Center National Distinction of Excellence based on meeting accreditation criteria, and through their ongoing performance registry reporting.

Key Points: 
  • Eisenhower Health was awarded the HeartCARE Center National Distinction of Excellence based on meeting accreditation criteria, and through their ongoing performance registry reporting.
  • "We are proud to be the Coachella Valley's only heart program to earn the HeartCARE Center distinction.
  • "ACC Accreditation Services is proud to award Eisenhower Health with the HeartCARE Center designation."
  • Eisenhower Health has proven to be a forward-thinking institution with goals to advance the cause of sustainable quality improvement.

Edwards Lifesciences Reports Fourth Quarter Results

Retrieved on: 
Tuesday, February 6, 2024

Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended December 31, 2023.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended December 31, 2023.
  • In the fourth quarter, Edwards remained focused on its key value drivers to unlock the significant long-term opportunity for patients: a portfolio of differentiated therapies; positive clinical trial results to support approvals and adoption; and favorable real-world clinical outcomes.
  • Research and development expenses in the fourth quarter grew 16 percent over the prior year to $270 million, or 17.6 percent of sales.
  • During the fourth quarter, the company repurchased $444 million of stock through a combination of a pre-established trading plan and accelerated share repurchase programs.

Tampa General Hospital Is the First and Only in the Southeast to Complete Transcatheter Mitral Valve Replacement (TMVR) with AltaValve Technology

Retrieved on: 
Tuesday, January 30, 2024

TAMPA, Fla., Jan. 30, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter. The patient suffered from severe mitral regurgitation (MR), a common heart disease that generally requires open heart surgery. The patient underwent the minimally invasive procedure in December at Tampa General's main campus on Davis Islands in downtown Tampa and was safely discharged after just two days.

Key Points: 
  • TAMPA, Fla., Jan. 30, 2024 /PRNewswire/ -- Tampa General Hospital (TGH) celebrated excellent results from its first transcatheter mitral valve implant (TMVR), making it the first and only hospital in the Southeast to complete a mitral valve replacement procedure via a catheter.
  • "At Tampa General, we're pioneering new technologies that can save lives, especially for the patients with the highest risk," said John Couris, president and CEO of Tampa General Hospital.
  • "The transcatheter mitral valve replacement was made possible by a multidisciplinary team of best-in-class professionals who don't just meet standards of care; they establish them.
  • In preliminary clinical trials of the AltaValve, patients experienced significant improvement in heart function and a reduction in symptoms of mitral valve regurgitation.

Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™

Retrieved on: 
Monday, January 22, 2024

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.

Key Points: 
  • Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.
  • This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023.
  • “Having been part of Pi-Cardia’s rigorous clinical program, I am thrilled to see the recognition in the importance of ShortCut™,” said Philippe Genereux, MD from Morristown Medical Center in New Jersey.
  • “Lifetime management of aortic stenosis calls for leaflet modification solutions like ShortCut™ to ensure that we are carefully addressing the risk of coronary obstruction before implanting a valve.

Teleflex Announces First Patient Enrollment in ACCESS-MANTA™ Registry

Retrieved on: 
Thursday, November 16, 2023

The registry will include appropriate patient selection and proper vascular access.

Key Points: 
  • The registry will include appropriate patient selection and proper vascular access.
  • Enrolling at least 250 patients in up to 15 major TAVR institutions across the US and Canada, the ACCESS-MANTA™ Registry is an international, multicenter, prospective, observational, single-arm clinical registry.
  • “Large bore access site complications are recognized as morbid,1 driving increased costs and prolonged length-of-stay,2” said Teleflex Interventional Medical Director, Christopher Buller, MD.
  • “We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA™ Registry,” said Dr. Khera, Co-Global Principal Investigator.

Vivasure Medical Announces First Patients Treated with PerQseal Elite Closure Device System

Retrieved on: 
Tuesday, December 12, 2023

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the first patient treated with PerQseal® Elite, the latest generation of the company’s fully absorbable large-hole closure system.
  • Ph.D., at Erasmus University Hospital in Rotterdam, The Netherlands, as part of the company’s ELITE Study—a prospective, multi-center, single-arm clinical study evaluating the safety and efficacy of PerQseal Elite.
  • PerQseal Elite leverages the legacy PerQseal system’s excellent safety profile and ease of use.
  • The company continues to enroll patients for its Investigational Device Exemption (IDE) clinical study for PerQseal and PerQseal+ in the United States.

Pi-Cardia Hires Gary Gratson to Lead Global Commercialization

Retrieved on: 
Monday, December 11, 2023

Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction.

Key Points: 
  • Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it hired Gary Gratson to lead commercial operations for ShortCut™, the world's first dedicated leaflet modification device to enable Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction.
  • This announcement comes after completion of enrollment in the ShortCut™ Pivotal Study in the US and Europe in September 2023.
  • In his new role, Mr. Gratson will be responsible for building and leading the US commercial organization, driving strategic initiatives, and contributing to the continued growth of Pi-Cardia.
  • "I am honored to join Pi-Cardia at such exciting times,” said Mr. Gratson.

Edwards Lifesciences Outlines Growth Strategy at Annual Investor Conference

Retrieved on: 
Thursday, December 7, 2023

Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s sharpened focus and strategy for longer-term growth, provide an update on its technology pipeline and share financial guidance1 today during its annual investor conference.

Key Points: 
  • Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s sharpened focus and strategy for longer-term growth, provide an update on its technology pipeline and share financial guidance1 today during its annual investor conference.
  • Continued progress across these areas will result in more patients diagnosed and treated with Edwards’ repair and replacement technologies, and a significant long-term growth opportunity.
  • Also in 2024, Edwards expects to accelerate its surgical mitral leadership with the global commercialization of its MITRIS RESILIA valve.
  • During the conference, Edwards’ management will reaffirm the company’s 2023 financial guidance and provide guidance for 2024.

Vivasure Medical Announces 100th Patient Enrolled in U.S. Pivotal Study

Retrieved on: 
Tuesday, November 14, 2023

Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.

Key Points: 
  • Vivasure Medical® , a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.
  • The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward.
  • “We’re grateful to the one hundred patients who have been enrolled in this study to date and the brilliant physician investigators working to gather data about our technology,” said Andrew Glass, Chief Executive Officer of Vivasure Medical.
  • The PATCH pivotal study will enroll and follow up to 188 patients across the U.S. and Europe.