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June 3 (Reuters) - Medtronic Plc said on Thursday it was stopping the sale and distribution of one of its heart pumps due to safety concerns, sending its shares down about 1% in premarket trading.
The decision comes after the company’s clinical comparisons showed a higher rate of neurological adverse events with its heart pump HVAD System than with other circulatory support devices.
The HVAD System, implanted in patients with advanced heart failure to increase blood flow, may experience a delay to restart or a failure to restart after it is stopped, Medtronic said.
Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization and result in death, it added.
Medtronic acquired the HVAD System in 2016 as part of its $1.1 billion purchase of heart pump maker HeartWare International Inc. The device is currently implanted in about 4,000 people.
“Medtronic is working closely with other stakeholders including Abbott, and with regulatory bodies globally, to help ensure that alternative treatment options are available,” it said in a statement.
The company said elective explant of the device was not recommended as the risks associated with it may outweigh the potential benefits.
Medtronic expects the move to be neutral to slightly positive to fiscal year 2022 adjusted profit. The HVAD System and associated accessories brought in revenue of $141 million in the fiscal year 2021.
Rival Abbott said on Thursday it had the capacity and supply to support the growing demand for heart pumps. The company sells the HeartMate 3 heart pumps.
“We see this as a neutral event for Medtronic and a minor positive to Abbott, which we expect should capture almost all of the lost HVAD sales as the only competitor on the market,” J.P.Morgan said in a client note. (Reporting by Dania Nadeem and Manojna Maddipatla in Bengaluru; Editing by Aditya Soni)