PERTH, Australia – Cardiovascular medical device company Venstramedical Ltd. has raised $2 million in seed funding to support development of a small catheter-inserted collapsible heart pump. The Sydney-based company is aiming to develop devices that provide cardiac support for failing hearts without the use of surgery, Venstramedical co-founder and CEO Martin Cook told BioWorld.

The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022.

PARIS – The High Authority for Health (HAS) in France recently published a 165-page report on use over 10 years of long term mechanical circulatory assist devices (MCS). HAS conducted this wide-ranging study to review the conditions for the management of MCS devices, technology that has been constantly evolving over the past decade.

Shanghai Heartcare Medical Technology Co. Ltd. shares took a hard fall in their Aug. 20 debut on the Hong Kong Stock Exchange (HKSE), closing at HK$129 (US$107.47) after tumbling all the way down to HK$127.8 earlier in the day.

Cardiac Dimensions Inc. launched the Empower trial of its Carillon mitral contour system for the treatment of heart failure patients with early-stage functional mitral regurgitation. The company expects to enroll up to 300 patients at 75 sites in the international, randomized, sham-controlled trial.

Jorge Ulloa of Hancock Jaffe Laboratories Inc. presented positive results from a first-in-human trial of implantation with its Venovalve device at the Society for Vascular Surgery annual meeting in San Diego. Two years following surgery, outcomes included more than 60% improvements in reflux and disease manifestations and 93% decrease in pain in patients with chronic venous insufficiency with no safety issues or venous ulcer recurrences.

PARIS – Magnetic fields can be used to stimulate blood vessel growth, according to a new study published in Science and Technology of Advanced Materials. The discovery, by researchers from the University of Lisbon in Portugal, could lead to new treatments for cancer and help regenerate tissues that have lost their blood supply.

Abiomed Inc. is one of a number of companies whose share prices took a hit in the early days of the COVID-19 pandemic, but the company has since rebounded, thanks in part to the news that the FDA has granted the company a breakthrough device designation for its Impella ECP device. The external counterpulsation (ECP) system may eventually make significant headway in the hemodynamic support space thanks to the small size of the device, a key feature for patients undergoing high-risk percutaneous coronary intervention (PCI) procedures.

Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder to treat people with atrial fibrillation who are at risk of ischemic stroke about a month earlier than generally expected, given the backlog at the FDA. The dual-closure device closes the left atrial appendage during the procedure, reducing the risk of blood clots immediately and eliminating the need for blood thinners both during the healing process and longer term.

The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed to drop its national non-coverage policy for pulmonary embolectomy, a procedure for which multiple devices have been cleared or approved by the FDA. Several stakeholders, including more than one med-tech trade association, had requested such a change, and CMS indicated that much more evidence will be needed before it can forge a national coverage policy that would eliminate the impending geographically differentiated patient access.