Abbott Continues Its Sterling 2023 with Epic Max FDA Approval

The company has seen multiple FDA nods and the acquisition of Cardiovascular Systems since the start of this year.

Katie Hobbins, Managing Editor

March 31, 2023

3 Min Read
FDA approval
Iryna Drozd / iStock via Getty Images

Abbott continues its positive start to 2023 with FDA approval of its Epic Max stented tissue valve to treat people with aortic regurgitation or stenosis. Aortic regurgitation is when the aortic valve doesn’t close properly and aortic stenosis is when it fails to open fully. When this happens, the heart doesn’t pump blood efficiently and blood flow to the body is reduced. Bioprosthetic valves like Epic Max, according to Abbott, are recommended for patients requiring valve replacement who aren’t suitable for taking blood-thinning medication.

The company’s stented tissue valve is designed to have favorable blood flow and its low-profile frame facilitates potential future transcatheter intervention in patients. It’s the latest addition to Abbott’s Epic surgical valve platform and built on the system for its long-term performance and durability.

 "With Epic Max, we're accomplishing two important things: First and foremost, we're improving heart valve hemodynamics, which is the purpose of the procedure,” said Michael Dale, senior vice president of Abbott's structural heart business. “Secondly, we're preserving options and ability for patient lifetime disease management, an ever more critical point of consideration in device therapy selection."

This news comes on the tail of what seems to be the start to a standout year for Abbott.

In January, the company announced FDA clearance for its newest transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis who are at high or extreme risk for open-heart surgery. The system is designed with a unique fabric cuff (NaviSeal) to reduce or eliminate the backflow of blood around the valve frame known as paravalvular leak.

"Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution," Dale said, in a previous MD+DI article. "Receiving this approval is a major next step in our mission to help people live better lives through better health."

In early February, Abbott acquired Cardiovascular Systems, a company long considered one of the most attractive medtech M&A targets. Of note, analyst at Needham & Co, Mike Matson, even suspected Abbott would be the most logical buyer in previous reports.

The company agreed to pay $20 a share for Cardiovascular Systems, valuing the deal at $890 million. Cardiovascular Systems Diamondback 360 and Stealth 360 peripheral orbital atherectomy systems use a diamond-coated crown attached to an orbiting shaft, which is designed to sand away plaque while preserving healthy vessel tissue.

"While [Abbott] has large coronary and peripheral vascular businesses, it lacks an atherectomy platform," Matson wrote in a previous report. "Additionally, [Cardiovascular Systems'] pipeline of additional products including thrombectomy devices, an intravascular lithotripsy (IVL) system, drug-coated balloons (DCBs), and a percutaneous ventricular assist device (pVAD) likely proved compelling to [Abbott]."

Lastly, in March, Abbott marked a significant milestone with FDA clearance of its Freestyle Libre 2 and FreeStyle Libre 3 integrated continuous monitoring sensors for integration with automated insulin delivery (AID) systems. AID systems are designed to help with diabetes management by automatically adjusting and administering insulin delivered by an insulin pump based on real-time glucose data from an integrated CGM device.

Discussing the approval, William Blair analyst Margaret Kaczor wrote that it is not expected to result in material change in CGM demand but may be impactful for AID players like Tandem and Insulet. 

"We expect that the announcement… may be more impactful for AID players, such as Tandem and Insulet, as Abbott’s reach and market share — particularly internationally — can benefit these companies that have been competing with the reach and scale of Medtronic," Kaczor wrote.

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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