Abbott touts new data for its minimally invasive structural heart therapies - MassDevice

AbbottABT) today announced late-breaking data on some of its structural heart disease products.

The data listed findings on the MitraClip system for transcatheter mitral valve repair, the TriClip system for transcatheter tricuspid valve repair and the Tendyne transcatheter mitral valve implantation system for mitral valve replacement.

Clinical and real-world data showed that transcatheter devices can dramatically change treatment approaches for complex cardiac conditions. The data also showed continuous positive outcomes for less invasive transcatheter therapies, further emphasizing the company’s commitment to advancing new treatment options for mitral regurgitation and tricuspid regurgitation.

MitraClip was shown to have leading safety and effectiveness. With real-world outcomes from four separate analyses, the device showed significant mitral regurgitation and reduction was achieved with the MitraClip NTR/XTR Systems in patients with primary or secondary mitral regurgitation. It studied more than 1000 patients who received Abbott’s third-generation device at 57 sites worldwide.

Tendyne shows long-lasting and severe mitral regurgitation symptom relief at two-year follow-up, according to the company. The study analyzed 100 patients with symptomatic, moderate to severe or severe mitral regurgitation that were treated in the EU clinical study of the system. It demonstrated the durability of mitral regurgitation elimination in 93.2% of patients, according to the company, the data supports the valve as a safe treatment option that can provide symptom relief and improved quality of life for people with mitral regurgitation who are also not eligible for open-heart surgery or transcatheter mitral valve repair.

“Historically, people who were ineligible for standard-of-care surgeries to treat their mitral or tricuspid regurgitation were limited to symptom management, which does not address the underlying condition,” Paul Sorajja, director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital, said in a news release. “These devices treat extremely complex valve diseases that are debilitating and progress to very serious conditions when left untreated. The late-breaking data show significant and consistent reduction in regurgitation, allowing the heart valve to function as it is intended.”

Additionally, the company’s TriClip for clip-based tricuspid valve repair device was showed sustained TR reduction in 87.1% of patients who received the device and a low all-cause mortality rate of 7.1% at one year. It also had a positive impact of right ventricular function with sustained improvements in right heart function.

Other devices in the data included the Amplatzer Amulet Left Atrial Appendage Occluder and the Portico transcatheter aortic valve replacement.

Amplatzer Amulet showed a consistent and high implant success rate with a successful implant rate of 99% and a low rate of procedural complications of 3.5%.

Portico with FlexNav showed continued safety and performance for patients suffering from severe aortic stenosis who are at high risk for open-heart surgery. The FlexNav delivery system had an enhanced safety profile for the Portico device, according to the company.

“At Abbott, we are advancing science and innovative technology to ensure people living with structural heart diseases have safe and effective treatment options,” said Michael Dale, senior vice president of Abbott’s structural heart business. “The data presented during this year’s PCR underscore our unwavering commitment to solve the health challenges of those managing debilitating heart conditions.”

Shares in ABT were up 2.63% to $89.60 apiece at market close today, despite a dip to $87 yesterday in mid-morning trading due to a price drop by Morgan Stanley.

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