FDA approves Abbott's Amplatzer Talisman System for PFO Closure in people at risk of recurrent Stroke

Latest Pharma News update

Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart – who are at risk of recurrent ischemic stroke. Expanding on the success of Abbott's Amplatzer PFO Occluder, the next-generation Talisman system offers an additional 30mm device size, and all Talisman PFO occluders come pre-attached to the delivery cable, reducing preparation time for doctors. The FDA also cleared the Amplatzer Talisman Delivery Sheath, used to deliver the occluder during implantation.

A PFO is a hole in the heart when the foramen ovale – a flap-like opening that is a normal part of fetal development allowing oxygenated blood to pass through the baby's heart and bypass the lungs – doesn't close as it should following birth. About one in four people have a PFO,[i] where the foramen ovale stays open, or is "patent." A PFO may cause stroke by allowing blood clots to pass from the right side of the heart to the left, from where they may travel to the brain. For patients who have suffered a stroke as a result of their PFO, physicians may opt for occlusion (or closure) of the PFO through a minimally invasive procedure using therapy like the Talisman system to seal off the opening to reduce the risk of another stroke.

Abbott's next-generation Talisman system builds off the company's industry-leading Amplatzer PFO Occluder, which has more than two decades of safety and effectiveness data and is the only approved solution in the U.S. designed specifically to close the PFO. The Talisman system provides the widest range of PFO occluder sizes in the U.S. through the addition of the new 30mm offering. Additionally, the Talisman device comes pre-attached to the delivery cable, reducing prep time ahead of the procedure and making it easier to use. Talisman is fully recapturable and repositionable to ensure optimal placement.

"Extensive clinical trial data and the latest guidance from industry organizations support PFO closure as an important treatment option to reduce risk of recurrent stroke in patients," said Lee MacDonald, M.D., structural cardiologist at South Denver Cardiology Associates. "With the new Talisman system now available in the U.S., doctors can treat a broader range of patient anatomies, and the preparation needed for PFO occlusion procedures is simpler and faster."

"Abbott's Talisman system improves the efficiency and effectiveness of the PFO occlusion procedure," said Michael Dale, senior vice president of Abbott's structural heart business. "Talisman is another example of our commitment to advance innovation of our market-leading heart devices to help people live better lives through better health."

For more information on the benefits of PFO closure, see guidance from the American Heart Association/American Stroke Association and the American Academy of Neurology.

For U.S. important safety information on Talisman, visit https://abbo.tt/AmplatzerTalismanISI.

Tags : #Abbot #Amplatzer #FDAApprovalLatest #FDANews

About the Author


Team Medicircle

Related Stories

Loading Please wait...
-Advertisements-


Trending Now

PM addresses the Nation today, announces free vaccinesJune 07, 2021
Why inhalers are best for treating asthma, well illustrated by Dr. Anil SingalMay 12, 2021
Dr. Rohan Palshetkar shares his invaluable insights about the Maternal Mortality Rate causes and improvements in India April 29, 2021
It is important to adopt a non-judgmental attitude towards any teenage girl seeking contraceptive advise suggests Dr. Teena Trivedi, Obstetrician and GynecologistApril 16, 2021
80% of the diseases are psychosomatic which means they have roots in the mind and this is where homeopathy steps in - It resolves physical ailments by finding the cause in the mind – Dr. Sanket Dhuri, Consultant Homeopath April 14, 2021
A futuristic Vision of a Healthcare Entrepreneur: Shyatto Raha, CEO, and Founder of MyHealthcareApril 12, 2021
Saher Mehdi, Founder and Chief Scientist at wellOwise talks about aspects making healthcare more equitable and reachableApril 10, 2021
Wide variety of therapies to address autism in children explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 09, 2021
Allopathic and Homeopathic medicines should not be taken together says Dr. Sunil Mehra, Homeopath ConsultantApril 08, 2021
The charm of homeopathic medicine is that it can be taken with conventional medicines – Dr. Shruthi Shridhar, Consulting Homeopath April 08, 2021
Dissociative Identity Disorder and associated concepts explained by Dr. Vinod Kumar, Psychiatrist and Head of Mpower - The Centre (Bangalore) April 07, 2021
Dissociative Identity Disorder explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 05, 2021
Sehat Ki Baat, Karishma Ke Saath- Episode 6 Healthy Diet For Boosting Metabolism Which Can Help Thyroid Patients April 03, 2021
Significant Pointers on Kidney Health by Dr. Santosh Waigankar, Consultant Urooncologist and Robotic Surgeon at Kokilaben Dhirubhai Ambani HospitalApril 01, 2021
Dr. Vaishal Kenia, Ophthalmologist Talks About the Different Possibilities Available for the Treatment of Glaucoma Depending Upon Their Type and SeverityMarch 30, 2021
No Definitive Role of Diet in Treatment of Lymphedema but Intake of Calories, Salt and Long Chain Fatty Acids should be controlled says Dr. Ramani CVMarch 30, 2021
Dr. Kiran Chandra Patro, Senior Nephrologist Talks About Dialysis as the Temporary Process and Not a Permanent Cure for the Patients of Renal DysfunctionMarch 30, 2021
Two out of three new chronic kidney disease patients are found to have diabetes or hypertension informs Dr. Sreeharsha HarinathaMarch 30, 2021
Glaucoma Treatment: Medications or Surgery? A valuable piece of advice from Dr. Pranay Kapdia, Chairman and Medical Director of Kapadia Eye CareMarch 25, 2021
Dr. Shraddha Satav, Consultant Ophthalmologist Recommends that Everybody After 40, Should Go for the Complete Eye Checkup at Regular IntervalMarch 25, 2021