U.S. FDA Grants 510(k) Clearance for Impella Low Profile Sheath

Rhea-AI Summary

Abiomed has received 510(k) clearance from the FDA for its new Impella Low Profile Sheath, enhancing ease of use by reducing the outer diameter by nearly 2 Fr while maintaining the inner diameter. This innovation enables simpler insertion and removal of Impella heart pumps, cutting down procedural steps and minimizing vascular complications. The Low Profile Sheath is specially designed for single-access technique, improving patient management in critical care. A phased rollout will begin this quarter.

Positive

• 510(k) clearance from the FDA for the new Impella Low Profile Sheath.
• Reduction in outer diameter enhances ease of insertion and removal of heart pumps.
• Designed to minimize vascular complications and procedural steps.

Negative

• None.

Smaller Sheath Simplifies Access and Improves Ease-of-Use

DANVERS, Mass.--(BUSINESS WIRE)-- The United States Food and Drug Administration (FDA) has granted 510(k) clearance to Abiomed (Nasdaq: ABMD) for its Impella Low Profile Sheath. Compared to the existing 14 French (Fr) sheath used for placement of Impella CP, the new sheath maintains the same inner diameter, but reduces the outer diameter by nearly 2 Fr. As a result of its smaller size and other technological advancements, the Low Profile Sheath will facilitate easier Impella insertion and removal, reduce procedural steps and help improve outcomes.

Abiomed’s 14 Fr Impella Low Profile Sheath, in its assembled state (Photo: Business Wire)

The Low Profile Sheath is the first sheath specifically engineered to be compatible with the Impella single-access technique, which removes the need for an additional access site. Additionally, it is designed to:

• Simplify access and ease-of-use by eliminating the peel-away sheath and the need for the re-access sheath for patients who are sent to the intensive care unit.
• Further minimize vascular complications and bleeding.
• Facilitate easier delivery into the vasculature with a hydrophilic coated long-taper dilator, reducing the need for multiple steps of serial dilation.
• Facilitate easier management of the patient during heart pump removal and vascular closure because Impella can be removed directly from the sheath without re-wiring.

“Abiomed’s Low Profile Sheath is a game changing technological achievement that will further improve patient outcomes by making it even easier for physicians to insert, manage and remove Impella heart pumps,” said Chuck Simonton, MD, Abiomed’s chief medical officer.

Abiomed will begin a phased roll-out of the Impella Low Profile Sheath this quarter.

ABOUT IMPELLA HEART PUMPS

Impella CP with SmartAssist® is U.S. FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, to reopen blocked coronary arteries.

Impella CP with SmartAssist® and Impella 5.5® with SmartAssist® are U.S. FDA approved to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.

ABOUT ABIOMED

Based in Danvers, Massachusetts, USA, Abiomed (Nasdaq: ABMD) is a leading provider of medical technology that provides circulatory support and oxygenation. Our products are designed to enable the heart to rest and recover by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure. For additional information, please visit abiomed.com.

FORWARD-LOOKING STATEMENTS

Any forward-looking statements are subject to risks and uncertainties such as those described in Abiomed's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221017005313/en/

Media Contact:

Jenny Leary

Associate Director, U.S. Communications

+1 (978) 882-8491

jleary@abiomed.com

Investor Contact:

Todd Trapp

Executive Vice President and Chief Financial Officer

+1 (978) 646-1680

ttrapp@abiomed.com

Source: Abiomed, Inc.

FAQ

What is the significance of the FDA's 510(k) clearance for ABMD?

The FDA's 510(k) clearance allows ABMD to market its new Impella Low Profile Sheath, which improves ease of use and patient outcomes.

How does the Impella Low Profile Sheath differ from previous models?

The Impella Low Profile Sheath has a nearly 2 Fr smaller outer diameter while maintaining the same inner diameter, facilitating easier insertion and management of Impella heart pumps.

When will Abiomed begin rolling out the new Impella Low Profile Sheath?

Abiomed plans to start a phased rollout of the Impella Low Profile Sheath this quarter.

What impact does the new sheath have on patient care?

The Low Profile Sheath simplifies access for healthcare providers, reduces vascular complications, and improves patient management during critical procedures.

What is the ticker symbol for Abiomed?

The ticker symbol for Abiomed is ABMD.