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/PRNewswire/ The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic s.
FDA alerts health care providers to no longer implant heart failure patients with Medtronic s HVAD System
The U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.
Medtronic is stopping the distribution and sale of the HVAD System and has issued an Urgent Medical Device Communication Notification Letter requesting physicians to stop new implants of the device. This action comes after the company received over 100 complaints involving delay or failure to restart of the HVAD pump, including reports of 14 patient deaths and 13 cases where an explant was neces
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Vancouver, British Columbia and Minneapolis, Minnesota (Newsfile Corp. - May 25, 2021) - Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) ( Neovasc or the Company ) announced today that it has received written notification (the Notification Letter ) from The Nasdaq Stock Market LLC ( Nasdaq ) notifying the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of US$1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company s common shares for the 30 consecutive business days from April 12, 2021 to May 21, 2021, the Company no longer meets the minimum bid price requirement.
Neovasc Inc.: Neovasc Receives NASDAQ Notification Regarding Minimum Bid Price Deficiency
Vancouver, British Columbia and Minneapolis, Minnesota (Newsfile Corp. - May 25, 2021) - Neovasc Inc. (NASDAQ: NVCN) (TSX: NVCN) ( Neovasc or the Company ) announced today that it has received written notification (the Notification Letter ) from The Nasdaq Stock Market LLC ( Nasdaq ) notifying the Company that it is not in compliance with the minimum bid price requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of US$1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company s common shares for the 30 consecutive business days from April 12, 2021 to May 21, 2021, the Company no longer meets the minimum