HeartWare Pipeline Update: HVAD On Track For 2012 PMA Approval

Firm notes that it has not yet heard from FDA on whether an advisory committee review will be required for its left ventricular assist device, intended as a bridge to transplant.

HeartWare International Inc. is aiming for PMA approval of its first left ventricular assist device by later this year, the company told analysts during a Jan. 9 session of the JP Morgan Healthcare Conference in San Francisco.

HeartWare had previously anticipated an FDA advisory panel review of its flagship HVAD pump by the end of 2011, and...

More from Archive

More from Medtech Insight

Medtronic, Philips Cement New Pact To Embed Next-Gen Tech In Monitoring Platforms

 
• By 

Under the terms of the new agreement, Philips will also begin bundling essential supplies – including ECG, noninvasive blood pressure (NIBP) components, and batteries – with its Medtronic-enabled monitors.

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By 

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By 

Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.