MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure

By

Abiomed's Impella 5.5 heart pumpAbiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure.

The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data on the device that showed a survival rate matching that of its pre-approval study when following the FDA’s approved protocol.

During the COVID-19 pandemic, Impella RP has been used for treating right heart failure or decompensation, including pulmonary embolism, according to a news release. It can be deployed in minutes using a minimally invasive technique.

The FDA granted EUA based on data from Impella RP’s approved indication and reported clinical experience. Under the authorization, healthcare providers may use the device in a hospital setting when providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2 who are experiencing acute right heart failure or decompensation caused by complications related to COVID-19.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19,” Ascension St. John Hospital (Detroit) interventional cardiologist & director of mechanical circulatory support Dr. Amir Kaki said in the news release. “Impella RP is an important tool to help cardiologists save lives during this pandemic. As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be life-saving.”

Kaki and Dr. Ted Schreiber cited an example of a 59-year-old woman from the Detroit area who used Impella RP therapy after being diagnosed with COVID-19 and an acute pulmonary embolism. The doctors described a “dramatic and immediate” arterial pressure improvement in the patient.

The Impella RP remained in place over the next five days as carers monitored the patient using cloud-based Impella Connect technology. On the fifth day, the device was removed and the patient was discharged.

“We appreciate the work of physicians and healthcare providers to treat these difficult patients and thank the FDA for its emergency use authorization for Impella RP,” Abiomed chairman, president & CEO Michael Minogue said. “We are committed to helping our customers improve the outcomes of their patients with our percutaneous heart pumps during these COVID-19 times.”

Shares of ABMD were down -1% at $221.70 per share in mid-morning trading today.

In case you missed it

RSS From Medical Design & Outsourcing

  • Medtronic CFO offers supply chain update as medical device industry concerns mount
    Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips. Still, CFO Karen Parkhill says the world’s largest medical device manufacturer is not in the same dire straits as chip buyers in other industries. Medtronic’s supply chain is “holding up OK, but… […]
  • SeaSpine warns of COVID-19 hit to surgical revenue
    SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business. Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout… […]
  • Women may have more adverse events with left atrial appendage occlusion devices than men
    Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today. In a letter to health care providers, the FDA said researchers have yet to determine the reason for the difference — and that it is working with device makers to… […]
  • A closer look at a microrobot that could treat a rare brain malformation
    Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers. The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation. In 1914, neurosurgeon Walter… […]
  • Heraeus buys Mo-Sci and ETS Technology Holdings
    The Heraeus Group has a deal to acquire Mo-Sci Corp. and ETS Technology Holdings, the Germany-based conglomerate announced this week. Mo-Sci is a supplier of glass microspheres, fibers and powders for medical devices, while ETS is the developer of bioactive glass fiber wound care product Mirragen, an FDA-cleared resorbable synthetic skin substitute. The companies —… […]
  • Medical Alley appoints new CEO
    The Medical Alley Association announced today that it appointed Roberta Dressen as its new president and CEO. Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then. Get the full… […]
  • Westfall Technik names Mark Gomulka as CEO
    Westfall Technik’s board of directors has nominated Mark Gomulka to lead the company. Gomulka joined the Las Vegas–based plastics manufacturer as SVP in January 2020. Before that, he led Flex’s medical and precision plastics operations for five years and earlier spent 15 years at Nypro in various global operational and leadership roles. In those positions… […]
  • The MedTech Conference by AdvaMed to be a mixture of in-person and virtual
    To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week. The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a… […]
  • Varta launches online battery monitoring feature
    Battery maker Varta has launched a cloud computing feature to let customers remotely monitor battery charging, health and the temperature of the battery management system. While Varta makes microbatteries for medical devices such as hearing aids, the new online monitoring dashboard is meant for its “Easy Block” and “Easy Blade” modular smart batteries. The smart… […]
  • Bionaut Labs wins humanitarian use device designation to treat rare pediatric brain disorder
    Microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat Dandy-Walker syndrome, a congenital brain malformation affecting the cerebellum. According to the National Organization for Rare Disorders, the syndrome affects one out of every 25,000 to 35,000 live births. There are currently… […]
  • Integer plans $30 million innovation and manufacturing facility in Galway
    Integer Holdings Corp. (NYSE: ITGR) plans to build a medical device innovation and manufacturing facility in the Parkmore East area of Galway, Ireland. Plano, Texas–based Integer said the initial phase of the project will total 60,000 square feet and a $30 million investment over the coming years, with construction scheduled from 2022 to late 2023… […]