Shares of HeartWare International (NSDQ:HTWR) plunged 20.8% after the company announced a buyout of Israeli replacement heart valve maker Valtech Cardio. HTWR shares closed at $64.82 apiece yesterday as investors reacted to the highly dilutive terms of the deal, which was worth some $929 million based on HeartWare’s closing price the day before it was announced. It’s now worth about […]
HeartWare International Inc.
HeartWare inks $929m deal for Valtech Cardio’s mitral and tricuspid valves
HeartWare International (NSDQ:HTWR) said yesterday that it agreed to put roughly $929 million on the table for Israeli replacement heart valve maker Valtech Cardio. Terms of the deal call for an up-front payment of 4.4 million shares of HeartWare stock, which would be worth about $360 million at yesterday’s closing price of $81.81. The buyout also […]
HeartWare completes enrollment in Endurance2 HVAD trial
HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system. The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said. Data from the 465-patient supplemental cohort trial will be […]
FDA warns on potential LVAD issues
The FDA published a safety communication today warning about issues with implantable left ventricular assist devices. The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system. Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s […]
HeartWare gains on Q2 sales & earnings beat
HeartWare International (NSDQ:HTWR) today reported 2nd-quarter results that beat expectations, despite a plunge to red ink, sending its stock price up more than 7%. The Framingham, Mass.-based implantable heart pump maker posted losses of -$27.4 million, or -$1.59 per share, on sales of $73.6 million for the 3 months ended June 30. That’s sales growth […]
Report: St. Jude Medical in talks to acquire Thoratec
St. Jude Medical (NYSE:STJ) is reportedly in talks to acquire Thoratec (NSDQ:THOR), according to “people familiar with the situation.” Although the 2 companies are in ongoing discussions, no final deal has been agreed and the negotiations may still fall apart, the sources told Bloomberg. Thoratec could also opt to seek a different buyer, 1 of the people said. THOR shares rose […]
HeartWare launches European trial for next-gen MVAD heart pump
HeartWare International (NSDQ:HTWR) said today that it’s launching a clinical trial aimed at winning CE Mark approval in the European Union for its next-generation MVAD implantable heart pump. The prospective, non-randomized, single-arm study is slated to enroll 60 patients, who will be implanted with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at 6 months, […]
Heartware issues HVAD recall
HeartWare International (NSDQ:HTWR) issued a field notice on its HVAD implantable heart pump over issues with worn alignment guides and connection pins that could lead to the pump stopping, according to the FDA. The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watch dog, indicating that “there is […]
HeartWare warns on HVAD issues
HeartWare International (NSDQ:HTWR) said today it issued a voluntary urgent medical device correction last month describing 5 complaints about its HVAD implantable heart pump. The 1st issue involves a possible degradation of the HVAD’s internal battery, causing a loss of a “double disconnect alarm” if both power sources that connect to the pump are disconnected, the report said. […]