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Last $78.80 USD
Change Today -0.82 / -1.03%
Volume 181.2K
HTWR On Other Exchanges
As of 8:10 PM 04/24/15 All times are local (Market data is delayed by at least 15 minutes).

heartware international inc (HTWR) Snapshot

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52 Week High
05/1/14 - $97.60
52 Week Low
12/11/14 - $69.05
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heartware international inc (HTWR) Details

HeartWare International, Inc., a medical device company, designs, develops, manufactures, and markets miniaturized implantable heart pumps or ventricular assist devices (VAD) for the treatment of advanced heart failure in the United States, Germany, and internationally. It offers HeartWare Ventricular Assist System, which comprises a VAD or blood pump, patient accessories, and surgical tools designed to provide circulatory support for patients in the advanced stage of heart failure. The company is also developing the MVAD, a miniaturized blood pump intended for chronic heart failure patients; and SYNERGY Circulatory Support System, a partial support system designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent. The company markets its products directly to clinicians and medical facilities, as well as through medical device distributors. HeartWare International, Inc. is headquartered in Framingham, Massachusetts.

585 Employees
Last Reported Date: 03/2/15

heartware international inc (HTWR) Top Compensated Officers

Chief Executive Officer, President, Managing ...
Total Annual Compensation: $541.3K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $324.8K
Chief Scientific Officer and Executive Vice P...
Total Annual Compensation: $331.6K
Senior Vice President, General Counsel and Se...
Total Annual Compensation: $329.2K
Senior Vice President of Sales & Marketing
Total Annual Compensation: $300.6K
Compensation as of Fiscal Year 2013.

heartware international inc (HTWR) Key Developments

Heartware International, Inc. Announces Data from its First Destination Therapy Clinical Trial Cohort, ENDURANCE

HeartWare International Inc. announced that data from its first destination therapy clinical trial cohort, ENDURANCE, successfully demonstrated that the trial achieved the primary endpoint. HeartWare's ENDURANCE clinical trial is a prospective, randomized, controlled, un-blinded Investigational Device Exemption (IDE) study designed to evaluate the HeartWare Ventricular Assist System as a destination therapy - or long-term therapy - for patients with end-stage heart failure who are ineligible for heart transplantation. Between August 2010 and May 2012, 446 patients were enrolled at 48 U.S. hospital centers and were randomly selected to receive either the HeartWare Ventricular Assist System or, as part of a control group, any alternative Left Ventricular Assist Device (LVAD) approved by the U.S. Food and Drug Administration (FDA) for Destination Therapy, in a 2:1 ratio. Investigators for the study reported that 55.0% of the investigational device patients attained the primary endpoint of the trial, which is stroke-free survival (Modified Rankin Score 4) at two years, defined as alive on the originally-implanted device, transplanted or explanted due to patient recovery. In comparison, 57.4% of patients in the control arm achieved the primary endpoint of the study. Based on these results for the primary endpoint of the ENDURANCE study, non-inferiority of the investigational device was established (p=0.0060). In the second destination therapy cohort, HeartWare is enrolling up to 310 HVAD patients, as well as up to 155 control patients, in a 2:1 randomization at 50 centers. The trial protocol approved by FDA was designed to confirm observations from ENDURANCE, that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events. The primary endpoint in the supplemental arm of the study is change in stroke incidence at 12 months on the originally-implanted device.

Heartware International Inc. Receives Approval from Health Canada to Market the HeartWare Ventricular Assist System

HeartWare International Inc. announced that it has received approval from Health Canada to market the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. The HeartWare Ventricular Assist System features the HVAD Pump, a small full-support circulatory assist device designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.

Heartware International Inc. - Shareholder/Analyst Call

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Price/Book 6.6x
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TEV/Sales 3.9x

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