|Over a month ago|
Abiomed price target raised to $335 from $280 at SVB Leerink » 08:2908/0708/07/20
SVB Leerink analyst…
SVB Leerink analyst Danielle Antalffy raised the firm's price target on Abiomed to $335 from $280 and keeps a Market Perform rating on the shares following the company's "meaningful" outperformance in Q1. While Antalffy says the ongoing COVID impact will likely cloud the base business trends in the near-term, the analyst notes that Abiomed has recovered faster than expected and the current trends are more encouraging than expected.
Abiomed not providing guidance due to COVID-19 » 07:2108/0608/06/20
Abiomed said in its Q2…
Abiomed said in its Q2 earnings release, "Due to the uncertain scope and duration of the COVID-19 pandemic and the timing of global recovery, the company has not provided full year revenue or operating margin guidance. The company will continue to analyze and monitor this dynamic environment and will continue to provide transparency around results and trends. The company will reassess after each quarter and provide an update on guidance as appropriate."
Abiomed reports Q1 EPS 98c, consensus 29c » 07:2008/0608/06/20
Reports Q1 revenue…
Reports Q1 revenue $164.85M, consensus $151.11M. "I am proud of Abiomed's execution during the COVID-19 pandemic, delivering on our Q1 RED phase commitments and maintaining our focus to recover hearts and save lives. We achieved sequential improvements in revenue and patients, strengthened our clinical data, and advanced our pipeline technology," said Michael Minogue, Abiomed's Chairman, President and Chief Executive Officer. "We will make fiscal year 2021 one of the most productive and transformative years for the company as we build Abiomed 2.0 and continue to innovate products that are smaller, smarter and more connected, while we pursue studies for Class I guidelines."
Abiomed: FDA issues EUA for Impella heart pumps for COVID-19 patients » 07:0408/0408/04/20
Abiomed said in a…
Abiomed said in a release, "The FDA has issued an emergency use authorization, or EUA, for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis. Impella is manufactured by Abiomed. COVID-19 causes widespread inflammation which can result in damage to the lungs and heart. This damage may cause severe left ventricular dysfunction manifesting as pulmonary edema and/or myocarditis. Impella combined with ECMO therapy (known as ECpella) has become an important tool for physicians treating COVID-19 patients suffering from both heart and lung failure. Impella is the world's smallest heart pump. It first received FDA clearance in 2008 and FDA PMA approval as safe and effective in 2015. During the last 10 years, Impella has provided left ventricular unloading to approximately 10,000 ECMO patients in cardiogenic shock. The FDA's EUA expands the use of Impella as an ECMO unloading therapy to include COVID-19 patients with pulmonary edema or myocarditis."
Abiomed: FDA issues EUA for Impella heart pumps for COVID-19 patients 07:0308/0408/04/20
Abiomed announces findings from three-year Impella heart pump study in Japan » 08:0907/3007/30/20
A three-year, investigator-led, prospective study of Japanese patients who received an Impella heart pump finds use of Impella is associated with a 77% survival rate at 30 days in AMI cardiogenic shock patients. The historic survival rate for cardiogenic shock is approximately 50%. The study, conducted with oversight by 10 Japanese professional societies, including the Japanese Circulation Society, or JCS, is the first to use the Japanese Registry for Percutaneous Ventricular Assist Devices, or J-PVAD, to investigate the efficacy and safety of Impella. J-PVAD data is independently monitored and shared with the Japan Pharmaceuticals and Medical Devices Agency, or PMDA. Lead investigator Yoshiki Sawa presented the interim analysis today as a late-breaking clinical study at the Annual Scientific Meeting of JCS. The interim analysis examined 819 patients treated with Impella for a variety of conditions, including cardiogenic shock and fulminant myocarditis, at 109 hospitals in Japan. Other findings include that Impella therapy is a highly effective treatment for fulminant myocarditis, with an 88% survival rate at 30 days. Overall, investigators conclude the favorable 30-day survival data indicates Impella is a beneficial therapy. A previous analysis of cardiogenic shock survival rates in Japan by Ueki et al, found a 32% survival rate at 30 days in patients who received venous-arterial extracorporeal membrane oxygenation. The comparatively high survival rates with Impella were achieved by following established best practices that include placing Impella pre-PCI, identifying cardiogenic shock early, using a right heart catheter, and reducing use of inotropes. The study's findings about the use of best practices are consistent with other published investigator-led studies, such as the National Cardiogenic Shock Initiative Study and the Inova study by Tehrani et al., that have demonstrated significant increases in survival with the use of Impella best practice protocols.
Abiomed announces FDA approval of data streaming from Impella console » 07:1207/1607/16/20
The FDA has approved…
The FDA has approved one-way digital data streaming during patient support from Abiomed's Automated Impella Controller, or AIC, the external console used with Impella heart pumps. Abiomed said in a release, "The data streaming capability is facilitated through the Impella Connect interface, a HIPAA-compliant, cloud-based remote monitoring platform that is currently installed at more than 200 hospitals. The approval means console data could be streamed live via Impella Connect to a secure server where artificial intelligence could provide predictive clinical information to the patient's physician."
Abiomed upgraded to Positive from Mixed at OTR Global » 09:4607/1307/13/20
OTR Global upgraded…
OTR Global upgraded Abiomed to Positive from Mixed following checks that indicate a recovery in procedures, sales force improvements, and feedback that cardiology practitioners continue to report high user satisfaction and reduced bleeding concerns.
Abiomed announces Impella 5.5 study published in ASAIO Journal » 07:1507/0107/01/20
The first published…
The first published United States experience of patients who received Abiomed's newest heart pump, Impella 5.5 with SmartAssist, finds 84% of the patients survived to explant with 76% native heart recovery. The study was published in the July edition of the American Society for Artificial Internal Organs , or ASAIO, Journal. The study examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center. The authors conclude Impella 5.5 with SmartAssist is safe and effective for a number of challenging clinical scenarios, including AMI cardiogenic shock. The 55 patients in the study were implanted with Impella 5.5 with SmartAssist between October 16, 2019 and March 4. Thirty-five patients were successfully weaned off the technology. Eleven patients went on to receive another therapy, two patients expired while on support and seven patients had care withdrawn. In total, 76.1% of survivors recovered native heart function. There were no device-related strokes, hemolysis or limb ischemia observed.
|Over a quarter ago|
Abiomed participates in a conference call with BTIG » 10:2506/2406/24/20
Medical Technology and…
Medical Technology and Digital Health Analyst Thibault holds a conference call with management on June 24 at 11 am hosted by BTIG.