The Irvine, CA-based company said it was limiting the device to only be available for use under clinical protocol with pre-screened patients that adhere to the current indications.
In 2014, renal denervation procedures to treat resistant hypertension took a crippling blow, when Medtronic failed to meet the primary endpoints in a trial, but recent activity from the Dublin-based firm and others indicates that the space is hot once again.
A recently-published meta-analysis showed higher mortality rates with Paclitaxel drug-coated balloons and drug-eluting stents, and at least two drug-eluting device trials have been paused.
FDA’s nod for the Sapien 3 Ultra valve comes at a time when the TAVR market is heating up with competition.
The Marlborough, MA-based company strengthens its structural heart portfolio and gains a deeper foothold in a market where Medtronic, Abbott Laboratories, and Edwards Lifesciences have already made significant acquisitions.
The Braintree, MA-based firm’s Paragonix SherpaPak Cardiac Transport System also has clearance for the adult patient population.
The Danvers, MA-based company is poised to invest $15 million in Shockwave Medical and work on a training and education program with the intravascular lithotripsy specialist.
The Galway, Ireland-based company has raised $30 million to help develop its approach to drain the excess fluid found in acute decompensated heart failure patients.
The partnership between Edwards Lifesciences and Bay Labs continues the trend of larger medtech firms teaming up with companies in the artificial intelligence space to enhance existing devices.
The Marlborough, MA-based company said it could pick up a CE mark for the endoscopic ablation system sometime in mid-2019.
JenaValve has received a nod from FDA to expand enrollment in an IDE of its TAVR system. The measure comes at a time when the TAVR landscape is expected to shift.
The developer of precision vascular robotics announced its CorPath GRX System was successfully used in robotic-assisted coronary interventions.
Daxor’s new technology designed to measure blood volume has the potential to reduce patient readmission rates and improve outcomes for patients suffering from acute heart failure.