Medical Device Daily

As expected, HeartWare (Framingham, Massachusetts) says it has submitted a pre-market approval (PMA) application to the FDA for the HeartWare ventricular assist system as a bridge to heart transplantation for patients with end-stage heart failure. The PMA filing had been expected by the end of the year (Medical Device Daily, Dec. 23, 2010).

The HeartWare ventricular assist system features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE marking for the HeartWare system in the European Union. The device is currently the subject of U.S. clinical trials for two indications, bridge-to-transplant (BTT) under a continued access protocol and destination therapy (DT).

The PMA submission includes data from HeartWare's pivotal ADVANCE clinical trial, an FDA-approved study designed to evaluate the HeartWare ventricular assist system as a BTT for patients with end-stage heart failure. Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010. The final implant in ADVANCE was performed in February, and the last follow-up evaluation at 180-days was in August.

Last month HeartWare released data from ADVANCE. The trial showed that 92% of the investigational device patients met the per protocol primary endpoint, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days. The trial also demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days, and the study also projected one-year survival of 91% using Kaplan-Meier analysis (MDD, Nov. 16, 2010).

Results for the comparator arm of the study, derived from 499 contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) demonstrated 90% success of the primary endpoint at 180 days. Based on these results for the primary endpoint of the ADVANCE study, noninferiority of the investigational device was established, the company noted.

Larry Biegelsen, senior analyst of medical supplies & devices at Wells Fargo Securities (San Francisco), said in a research note Tuesday he expects HeartWare to win FDA approval for the HVAD device in about 10 to 12 months, paving the way for U.S. launch in late 2011 or early 2012. Biegelsen added that he expects HeartWare to capture 60% of the U.S. BTT (bridge-to-transplant) market by 2015 resulting in overall U.S. share of 43% and global share of 46% by 2015.

Canaccord Genuity (Toronto) analyst Jason Mills told MDD last week that HeartWare is in an even better position to begin a robust build-out of its U.S. sales and support infrastructure after having recently completed a $125 million convertible note transaction.

HeartWare completed an offering of $125 million of convertible senior notes ($143 million with over-allotment) due 2017 with a 3.5% coupon. There was also a concurrent public offering of 900,000 shares (1 million with over-allotment) of common stock held by Apple Tree Partners at $81.31. The company is not receiving any proceeds from the stock sale.

Mills said the funding gives HeartWare the capital it needs to compete with Thoratec (Pleasanton, California) in the U.S.

According to Mills, the company is expected to receive HVAD DT approval in 2015, but sooner if PMA filing happens early. Mills predicts HeartWare will become a profitable company on a net income basis in late 2012 or early 2013 (MDD, Dec. 23, 2010).

The ADVANCE trial data released last month made for a difficult day for shareholders of Thoratec, one of HeartWare's competitors that has a prominent position in the market with more than 90% share. Still, Mills said in a November research note that Thoratec should not be written off. Yet Canaccord reduced its price target of Thoratec at that time to $43 from $52 to account for HeartWare's strong ADVANCE data, and raised its HeartWare price target to $98 from $84 (MDD, Nov. 16, 2010).

Another major competitor for HeartWare is Abiomed (Danvers, Massachusetts), which makes the Impella heart pump. Earlier this month Abiomed abruptly ended its PROTECT II study of the Impella, which was designed to study major adverse events in high-risk percutaneous coronary intervention patients who received support with Impella 2.5 vs. intra-aortic balloon pumps.

Abiomed cited over-anxious physicians as a primary reason for stopping the trial. Apparently, the company noticed that physician behavior was substantially different in each subgroup of the study, likely in part due to perceived superiority of support offered by the Impella device. Still, the company said it is optimistic about some of the data that came from the study of the device (MDD, Dec. 8, 2010).

Amanda Pedersen, 309-351-7774;