The restrictions on elective surgeries as hospitals struggle to manage the unfolding global pandemic are hitting medical device companies particularly hard. Abiomed Inc., which specializes in a tiny, minimally invasive heart pump to support heart failure patients, saw its first fiscal fourth-quarter revenue flatten as procedures were postponed. Still, U.S. revenue remained stronger than Wall Street had expected, even as ex-U.S. revenue had deeper declines.
Temporary cardiac pacing is often required for hospitalized cardiac patients, particularly for increasingly common transcatheter aortic valve replacement (TAVR) procedures. Startup Atacor Medical Inc. has raised a $25 million series B round to back its development of a novel extracardiac temporary pacing system. Intriguingly led by an undisclosed corporate partner, the financing is slated to get the company through a U.S. and European pivotal trial, as well as regulatory review in those regions. The San Clemente, Calif.-based startup also aims to continue developing interim and permanent iterations of its system.
Keeping you up to date on recent developments in cardiology, including: Helping heart cells regenerate; Heart failure hormone has role in sepsis; Speeding up ER treatment; Cheating cell death improves infarct outcomes.
Portland, Ore.-based startup Viscardia Inc. has received breakthrough device designation from the FDA for its implantable Visone system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. The minimally invasive implant works by stimulating a specific portion of the diaphragm.
Paris-based health care startup Cardiologs Technologies SAS has launched a clinical study to assess the use of its artificial intelligence (AI) platform to remotely monitor cardiac safety in COVID-19 patients being treated with the malaria drug hydroxychloroquine. The study could help to detect and prevent serious cardiac effects of the drug.
Pi-Cardia Ltd. has raised a $27 million round of financing led by Sofinnova Partners. The Rehovot, Israel-based company will use the round to back parallel U.S. feasibility and European pivotal trials of its catheter-based, nonimplant heart valve calcification treatment.
The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.
Keeping you up to date on recent developments in cardiology, including: Modeling the post-infarct heart; Researchers: Cancer immunotherapy poses threat to heart muscle; Lighting up the path for heart procedures.
Wayne, Pa.-based Intact Vascular Inc. has secured U.S. FDA approval for the first peripheral vascular implant to repair below-the-knee (BTK) post-angioplasty dissections. The company expects to begin shipping units of the Tack endovascular system (4F) in about two weeks.
Keeping you up to date on recent developments in cardiology, including: women can reduce stroke risk; Researchers see promise as stroke-damaged rat brains are repaired; Questions raised over blood pressure devices for home monitoring.