MitraClip

Abbott Receives FDA Approval for Expanded Indication for MitraClip™ Device

Retrieved on: 
Thursday, March 14, 2019
Medicine, Valvular heart disease, Human anatomy, Heart, Interventional cardiology, MitraClip, Mitral valve, Indication, Abt, Heart valve

ABBOTT PARK, Ill., March 14, 2019 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for a new, expanded indication to its leading MitraClip device used to repair a leaky mitral valve without open-heart surgery.

Key Points: 
  • ABBOTT PARK, Ill., March 14, 2019 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it received approval from the U.S. Food and Drug Administration (FDA) for a new, expanded indication to its leading MitraClip device used to repair a leaky mitral valve without open-heart surgery.
  • The new, expanded indication addresses the secondary form of MR and significantly increases the amount of people with MR able to be treated with MitraClip.
  • "The expanded indication of MitraClip opens new doors for these ailing patients and can improve their quality of life and chance of survival despite their complex condition."
  • "The expanded indication for MitraClip is a direct result of the dedication of our employees as well as our remarkable clinical investigators."

FDA approves new indication for valve repair device to treat certain heart failure patients with mitral regurgitation

Retrieved on: 
Thursday, March 14, 2019
Heart diseases, Circulatory system, Valvular heart disease, Cardiovascular system, MitraClip, Mitral insufficiency, Cardiac resynchronization therapy, Mitral valve, Regurgitation, Atrial fibrillation, Heart valve, Mitral valve prolapse

When first approved in 2013 , the MitraClip Clip Delivery System (MitraClip) was indicated to reduce mitral regurgitation in certain patients whose significant mitral regurgitation and heart failure symptoms result from abnormalities of the mitral valve (commonly known as primary or degenerative mitral regurgitation) and whose risks for mitral valve surgery are prohibitive.

Key Points: 
  • When first approved in 2013 , the MitraClip Clip Delivery System (MitraClip) was indicated to reduce mitral regurgitation in certain patients whose significant mitral regurgitation and heart failure symptoms result from abnormalities of the mitral valve (commonly known as primary or degenerative mitral regurgitation) and whose risks for mitral valve surgery are prohibitive.
  • The new indication, approved today, is for treatment of patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation because of diminished left heart function (commonly known as secondary or functional mitral regurgitation) despite being treated with optimal medical therapy.Optimal medical therapy includes combinations of different heart failure medications along with, in certain patients, cardiac resynchronization therapy and implantation of cardioverter defibrillators.
  • A small percentage of these patients also have moderate-to-severe or severe secondary mitral regurgitation, increasing the risks and complicating the treatment of their heart failure.
  • Potential adverse events from the device and implant procedure include death, stroke, major bleeding, and erratic heart beat (atrial fibrillation).

HighLife Closes a €32 Million Round B Financing

Retrieved on: 
Thursday, January 17, 2019
Surgery, Health, Biotechnology, Hospitals, Medical devices, Other Health, Professional services, Finance, Research, Science, Valvular heart disease, Circulatory system, Heart, Medicine, Cardiac surgery, Mitral valve replacement, Sofinnova, Heart valve, Mitral valve, Regurgitation, Mitral insufficiency, MitraClip

HighLife SAS, a medtech company focused on the development of a unique transcatheter mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation, announced today it had closed a 32 million round of equity financing.

Key Points: 
  • HighLife SAS, a medtech company focused on the development of a unique transcatheter mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation, announced today it had closed a 32 million round of equity financing.
  • The Series B round was co-led by U.S. Venture Partners (USVP) and Andera Partners, with Sectoral Asset Management and Jose Calle Gordo, Chairman of the company, joining the round.
  • Sofinnova Partners, which led the Series A round, continues to support the company and participated in this latest round of financing.
  • I am very pleased to announce the closing of the Series B financing round, which is essential to funding the development program of the company.

Neovasc Announces Third Quarter 2018 Financial Results Conference Call and Webcast

Retrieved on: 
Wednesday, November 7, 2018
Circulatory system, Cardiology, Valvular heart disease, Heart, Acute pain, Angina, Mitral valve, Heart valve, Mitral insufficiency, Cardiac surgery, MitraClip

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.

Key Points: 
  • Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace.
  • Its products include the Neovasc Reducer (the "Reducer"), for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and the Tiara (the "Tiara"), for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States , Canada and Europe .
  • For more information, visit: www.neovasc.com .

Landmark Study Shows Treatment with Abbott's MitraClip® is Superior to Medical Therapy for Advanced Heart Failure Patients with Significant Secondary Mitral Regurgitation

Retrieved on: 
Sunday, September 23, 2018
Valvular heart disease, Circulatory system, Cardiology, Medicine, MitraClip, Mitral insufficiency, Regurgitation, Heart failure, Mitral valve, Clinical endpoint, Mitral valve prolapse

The landmark COAPT study met both the primary safetyand efficacy endpoints andall secondary endpoints, and showed treatment with MitraClip plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years.

Key Points: 
  • The landmark COAPT study met both the primary safetyand efficacy endpoints andall secondary endpoints, and showed treatment with MitraClip plus medical therapy was superior to medical therapy alone in reducing rates of heart failure hospitalizations and improving survival at two years.
  • This therapeutic mitral valve intervention is the first and only to demonstrate positive outcomes in a clinical trial for ailing heart failure patients with clinically significant secondary mitral regurgitation.
  • In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) study, 614 symptomatic heart failure patients with moderate-to-severe or severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone at 78 sites in the U.S. and Canada.
  • MitraClip is currently under investigation to treat clinically significant secondary mitral regurgitation in the U.S. and not approved by the FDA for secondary mitral regurgitation.

Abbott Receives FDA Approval for Next-Generation MitraClip® Device to Treat People with Leaky Heart Valves

Retrieved on: 
Thursday, July 12, 2018
Medicine, Medical devices, Valvular heart disease, Interventional cardiology, MitraClip, Health, Food and Drug Administration, Cardiac surgery

The additional clip size is designed to help doctors treat patients who have more complex anatomies when repairing the mitral valve.

Key Points: 
  • The additional clip size is designed to help doctors treat patients who have more complex anatomies when repairing the mitral valve.
  • Abbott received CE Mark for the next-generation device earlier this year, allowing for sale of the devices in the European Union and other countries that recognize this regulatory designation.
  • "Abbott engineers designed these enhancements based on feedback from doctors to improve device delivery and to treat more types of cases and anatomies," saidMichael Dale, vice president for Abbott's structural heart business.
  • MitraClip received initial CE Mark approval inEuropein 2008 and was approved by the FDA in 2013.