The Danvers, Mass.-based company said its devices are the “1st and only percutaneous temporary ventricular support devices” to win Japanese PMDA approval and be deemed safe and effective for their indication.
“This approval marks a significant milestone to provide Impella hemodynamic support for heart failure patients. We commend the dedication of Japanese physicians and regulatory bodies in searching for new treatment options to improve patient outcomes and quality of life, and enable cost-effective solutions. We are pleased that the field of heart recovery with percutaneous heart pumps has begun in Japan,” chairman president & CEO Michael Minogue said in a press release.
Abiomed added that it is opening a larger office in Tokyo, picking up clinical support staff and submitting for future Japanese reimbursement.
The new facilities are slated to feature on-site training and certification programming, with distribution support starting in the 4th quarter of the fiscal year 2017. The company said it did not expect to see material revenue until its fiscal year 2018.
In July, Abiomed lifted its revenue guidance for the year after posting a Street-beating 1st quarter. The company reported profits of $12.9 million, or 29¢ per share, on sales of $103 million for the 3 months ended June 30. That amounts to a healthy 45.7% bottom-line gain as sales grew 40.3% compared with the same period last year.
Abiomed handily beat Wall Street analyst’s expectations of 23¢ in EPS and $97.2 million in revenue.
In April, Abiomed said it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery.
The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs and to allow for recovery of the native heart.