STS 2021 presents results of a large clinical study showing 79% survival with Impella 5.5 with SmartAssist

This is the first large-scale, multicenter study to analyze the survival rate of patients treated with Impella 5.5 with SmartAssist. The results of the study were at the 2021 Annual Meeting of the American Association of Thoracic Surgeons (STS) , the lead author, Dr. Edward Soltes, a cardiovascular and heart transplant surgeon (MD, MPH, Cleveland Clinic, Miller Family, Institute for Cardiovascular and Chest Diseases ). Announced. Data were taken from the Impella Quality (IQ) database and analyzed for facilities with more than 10 patients treated with Impella 5.5 with SmartAssist.

The authors conclude that Impella 5.5 with SmartAssist performed well with clinical outcomes and device outcomes, including:

• Overall patient survival 79% (n = 301)
• Survival rate 86% (n = 141) in patients with cardiogenic shock due to cardiomyopathy
• Survival rate 67% (n = 88) in patients with cardiogenic shock due to AMI
• Survival rate 68% (n = 34) in patients with cardiogenic shock after open heart surgery

Dr. Soltes said: “By adopting a new approach to support these critically ill patients, we were able to achieve an overall survival rate of 79%. We look forward to more prospective studies on this minimally invasive, high flow primary auxiliary device. . “

Dr. Scott Sylvestri (MD, Orlando, Advent Health, Chest Transplantation / Chest Surgery / Cardiovascular Surgery, Chief of Surgery), who co-authored the study, said: “This report demonstrates the significant left ventricular load reduction benefits of using Impella 5.5 in patients with cardiogenic shock. We use Impella 5.5 with conventional therapies. We are impressed with the improved survival rates in comparison. With best practices and techniques, and this innovative new technology, we can provide patients with better treatment prospects. “

Research presentations at STS provide further evidence of improved outcomes with the use of Impella 5.5 with SmartAssist. A study published in the July issue of the American Society for Artificial Internal Organs (ASAIO) Journal found 84% survival on withdrawal from Impella 5.5 support with SmartAssist in patients with cardiogenic shock and other difficult-to-treat heart diseases. It turned out to be. 76% of these patients achieved recovery of autologous heart function. The study examined the outcomes of 55 patients who were first treated with Impella 5.5 with SmartAssist at the Cleveland Clinic, Hackensack University Medical Center / Hackensack Meridian Health, and Cedars Sinai Medical Center.

In 2019, Impella 5.5 with SmartAssist was approved by the US Food and Drug Administration (FDA) for the highest level of safety and efficacy as a treatment for cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist delivers peak flow rates of over 6 liters per minute. The advantages of Impella 5.5 with SmartAssist are as follows.

• Impella Connect: Cloud-based remote monitoring
• Ease of insertion: Can be inserted via the axillary artery or ascending aorta
• Designed for long-term assistance: patient walking, with ceramic bearings, no pigtail
• Anterograde assistance that maximizes cardiac load: Achieves cardiac rest by terminal organ perfusion and coronary artery perfusion
• Achieves recovery of self-cardiac function: Minimally invasive and detachable left ventricular assist device
• Ease of patient management: SmartAssist enables intelligent pump positioning, withdrawal, and management

Some COVID-19-related complications receiving extracorporeal membrane oxygenation (ECMO) treatment in the United States from the FDA in August 2020 for all left ventricular Impella heart pumps, including Impella 5.5 with Smart Assist Obtained an Emergency Use Authorization (EUA) to treat patients .

Participants in STS 2021 are encouraged to attend two symposiums related to Impella 5.5 with SmartAssist.

• “Role of Surgeon: Managing the Shock Patient and Escalation”, Presenter: Dr. Zain Khalpey (MD, PhD), Northwest Medical Center (Tucson). This symposium will be held on Friday, January 29th, from 3:30 pm to 4:00 pm.
• “Post Cardiotomy Cardiogenic Shock (PCCS): Is it Time for a New Strategy?”, Dr. Scott Silvestri of Advent Health (Orlando) Moderated by Dr. Zain Khalpey (MD, PhD) at Northwest Medical Center (Tusson), Dr. Masahiro Ono (MD, PhD) at Methodist Hospital (San Antonio), and Danny Ramsey at Cedars Sinai Medical Center (Los Angeles). A panel discussion was held by a doctor and Dr. Dean Smith of NYU Langone Health Center (New York City). This symposium will be held on Sunday, January 31st, from 7:30 am to 8:30 am (Eastern Standard Time).

About IMPELLA Heart Pump

Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD®, Impella 5.5 ™ with SmartAssist® are US foods as cardiac pumps for the treatment of patients with acute heart failure cardiomyopathy in cardiogenic shock It is approved by the Pharmacy (FDA) and has a unique function that enables the natural recovery of the heart, allowing patients to recover their heart function and return home.

Also, the Impella Left Ventricular (LV, left ventricle) assistive device was confirmed to be infected with COVID-19, received ECMO treatment, and developed pulmonary edema during venous-arterial (VA) ECMO adjuvant therapy. Temporary Health Providers (HCP) in a hospital environment to treat emergency patients who develop late cardiac insufficiency due to myocarditis during venous-venous (VV) ECMO adjuvant therapy (Impella 2.5, Impella CP, Within 4 days for Impella CP with SmartAssist, within 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) Emergency use for left room load reduction and assistance is also permitted. The licensed Impella LV assist device has not been approved or approved for the approved indication. Impella RP and Impella LV aids have been approved by the EUA under the FDA for the above emergency use and are subject to Federal Law 21 USC § 360bbb-3 (b) (1) unless the authorization is terminated or revoked early. It is permitted only during the period of the declaration that there is a situation justifying the emergency use authorization of the medical device under Section 564 (b) (1) of.

About Abiomed

Based in Danvers, Massachusetts, Abiomed is a leader in circulatory assist devices and oxygenation devices. Our products improve hemodynamics and provide sufficient oxygen to patients with respiratory failure to reduce the burden on the myocardium and aim to recover it. For more information , please visit www.abiomed.com .

Forward-looking statement

This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties, such as those stated in the periodic report submitted by Abiomed to the US Securities and Exchange Commission. Actual results may differ materially from expected results.

This press release is a Japanese translation of the English press release released by Abiomed, Inc. of the United States on January 29, 2021 local time. The official language is English, which includes content that does not apply to Japan. English is prioritized for interpretation.

The official version of this press release is the original language version. The translated language version is provided for the convenience of the reader and has no legal effect. When using the translated language version as a material, please compare it with the original language version, which is the only version that has legal effect.