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Thoratec Corporation is an American-based medical device company that is publicly traded on the NASDAQ. It designs, manufactures, sells, and supports products that treat a wide range of clinical needs for advanced heart failure patients, specifically proprietary medical devices for circulatory support, vascular graft applications, point-of-care diagnostic test systems, and skin incision products. The company's product lines include the Thoratec VAD, HeartMate LVAS (Left Ventricular Assist System), and the CentriMag Blood Pumping System. As of 2013, over 20,000 Thoratec devices had been implanted in patients with advanced heart failure across the globe.

Headquartered in Pleasanton, California, Thoratec has offices and manufacturing facilities in Burlington, Massachusetts; Rancho Cordova, California; Edison, New Jersey; and Cambridgeshire, United Kingdom.

History
Thoratec Corporation was incorporated in California in March 1976 using the name Thoratec Laboratories Corporation. It began trading publicly on the NASDAQ on May 18, 1981. In 1988, Thoratec's "artificial heart" was listed by Fortune as one of the "100 Products That America Makes Best." In 1994, the U.S Food and Drug Administration (FDA) approved the HeartMate IP LVAD (Left Ventricle Assist Device), which was the first "bridge-to-transplant" implantable LVAD made commercially available in the United States. In that same year, the original HeartMate IP received the European Conformity Mark, making it available in European markets. It was given Canadian approval in 1998. The HeartMate IP was an implantable pneumatic LVAS powered by an external electrically-driven air-pump.

The successor to the HeartMate IP was the HeartMate VE, an electric LVAS that was driven by an implanted electric motor and powered by a lightweight battery pack worn by the patient. It received the European Conformity Mark in 1995 and was approved for use in clinical trials by the FDA later that year. The REMATCH clinical trial oversaw the first successful implantation of the HeartMate VE in May 1998. By September of that year, the FDA approved the HeartMate VE for commercial sale. The VE was used in Europe as a bridge to transplant and as a destination therapy. In 1995, Thoratec's Paracorporeal Ventricular Assist Device (PVAD)—-an external, pulsatile, ventricular assist device—-was approved by the FDA as a bridge to transplant. It would later be approved for postcardiotomy support in 1998.

The REMATCH trial officially ended in 2001 with positive results. 52% of the patients who used the HeartMate device survived while only a quarter of the patients who used standard medical therapy survived. The company intended to release the full results of the REMATCH trial on September 11, 2001, but were largely preempted by the September 11 attacks. Thomas Burnett, Thoratec's COO at the time and one of the key supporters of the REMATCH trial, was on the ill-fated United Airlines Flight 93. Burnett was among the members of the passenger revolt that succeeded in crashing the hijacked plane into an empty field in Stonycreek Township, Pennsylvania.

Also in 2001, Thoratec merged with publicly traded Thermo Cardiosystems, Inc., a Massachusetts-based manufacturer of cardiac assist, blood coagulation testing, and skin incision devices. Upon completion of the merger, Thoratec changed its name from "Thoratec Laboratories Corporation" to "Thoratec Corporation." Shares of Thermo Cardiosystems ceased trading while Thoratec shares continued on the NASDAQ. The merger increased Thoratec's customer base to more than 350 hospitals and 700 employees.

The following year, the FDA determined that the use of the HeartMate SNAP-VE LVAS as destination therapy for NYHA Class IV patients with end-stage ventricular failure was applicable. The HeartMate VXE, the successor to the HeartMate VE LVAS, would be granted the same distinction in 2003. Thoratec then began focusing its attention largely on the HeartMate II, a left ventricular assist system (LVAS) that is implanted alongside a patient’s native heart with the purpose of pumping for the heart’s left ventricle. It is very similar in style and function to the HeartMate VXE, but many studies have shown that the HeartMate II, which operates with continuous rather than pulsatile flow, is more reliable in a number of areas. One study by the American Heart Association even noted a 58% survival rate with continuous flow mechanisms in the second year compared to a 24% survival rate for pulsatile flow mechanisms in the same time span. The HeartMate II earned a CE Mark in 2005 and FDA approval in 2008 for use as a bridge to transplant. On January 20, 2010, it became the first LVAD approved by the FDA for destination therapy. The HeartMate II is also the first LVAS to achieve widespread use. As of 2012, the HeartMate II had been implanted in over 11,000 patients, including former Vice President of the United States, Dick Cheney, and Ally Smith, the "Bionic Bride" who married her college sweetheart after receiving the implant.

During this time, Thoratec also improved on its PVAD design by releasing the IVAD (Intracorporeal Venricular Assist Device). Most of the features found in the IVAD are identical to the PVAD except that the IVAD can be implanted inside a patient's body. The IVAD was approved by the FDA in 2004. The PVAD and IVAD devices have been implanted in over 3,000 patients throughout the world.

In 2009, Thoratec made a bid to acquire competitor HeartWare International in a transaction valued at approximately $282 million. The United States Federal Trade Commission announced that they planed to challenge the merger in what the Commission stated would be a substantially reduced competition for life-saving heart devices on the U.S. market. Thoratec subsequently terminated the agreement due to the FTC's strong opposition of the merger.

The following year, Thoratec purchased the heart-pump technology of Swedish company Getinge in a deal valued at $8.5 million. The technology consisted of a percutaneous heart pump driven by an external motor that pushed 4.5 liters of blood per minute. Thoratec used the technology for the development of axial-flow pumps that can be placed into the heart by using a minimally invasive catheter procedure.

By 2012, Thoratec had worked to get the HeartMate II approved in Japan, which they achieved by December of that year. In April 2013, post-approval study data on the HeartMate II were presented at the International Society for Heart and Lung Transplantation (ISHLT) 33rd Annual Meeting and Scientific Sessions in Montreal, Canada. The post-approval study analyzed the first 247 patients implanted with a HeartMate II device. Results showed a trend toward improved survival over two years, and adverse event rates were similar to or lower than the clinical trial experience. In addition, the median length of stay after surgery was reduced by six days in post approval versus in the clinical trial. Thoratec also celebrated the commercial release and FDA approval of their new Pocket Controller and the successful use of a HeartMate Percutaneous Heart Pump (PHP) implant in 2013. The two people to have lived the longest with HeartMate II implants are Joe Ann Bivins (2005 to 2014) and David Pierce, who has had his since 2004.

In June of 2014, Thoratec announced launch of the HeartMate III CE Mark trial and the first human implant of the device at Hannover Medical School in Hannover, Germany. The trial is scheduled to enroll up to 50 patients at nine sites in Europe, Australia, and Canada. The following month, Thoratec acquired Apica Cardiovascular Limited for an upfront cash payment of $35 million and potential future clinical and sales milestones of up to $40 million. Employees that were part of Apica at the company's facilities in Ireland and the United States were transitioned to Thoratec.

Products
Thoratec offers a broad range of mechanical circulatory support devices. The Company is focused on developing new technologies and the approval of new therapy and product indications for its current products.


 * HeartMate II is a left ventricular assist device (LVAD) that is implanted alongside a patient’s native heart with the purpose of pumping for the heart’s left ventricle. The HeartMate II is surgically implanted just below the diaphragm in the abdomen and attached to the aorta, leaving natural circulation in place as it assists in providing energy to propel blood throughout the body as a healthy left ventricle would.  The HeartMate II is designed to have a longer functional life that the previous generation of devices and to operate more quietly. Patients with the HeartMate II can be discharged from the hospital and the portability of the device’s components makes it easier for the patient to remain active.  The FDA approved the HeartMate II for bridge to transplantation Therapy in April 2008 and for destination therapy in January 2010.
 * PVAD (Paracorporeal Ventricular Assist Device) is an external, pulsatile, ventricular assist device, that was FDA-approved for Bridge to Transplantation (BTT), including home discharge, and post-cardiotomy recovery, and provides left, right or biventricular support. The PVAD is also the basis for further Thoratec product innovations.
 * IVAD (Implantable Ventricular Assist Device) is based on the PVAD design and is an implantable, pulsatile, ventricular assist device, that was FDA-approved for BTT, including home discharge, and post-cardiotomy myocardial recovery, and provides left, right or biventricular support.
 * CentriMag is a left ventricular assist system can be used for perioperative or postcardiotomy circulatory support of the failing heart. The device is manufactured by Levitonix LLC and resides at the patient's bedside. The cannulae are usually inserted through a midline sternotomy, with the inflow cannula in the left ventricle or right superior pulmonary vein and the outflow cannula in the aorta.
 * PediMag is the pediatric version of the CentriMag – an external device designed for short-term use in infants with heart failure. PediMag can also be used to support children after heart transplant surgery if they experience organ rejection and need time for their hearts to rest and heal.

Destination study, HeartMate II
At a late session during the November 17, 2009 American Heart Association's scientific sessions, investigators presented data from a two-year randomized trial where patients with advanced heart failure who were ineligible for a heart transplant were implanted with either a HeartMate XVE pulsatile LVAD (66 patients) or the HeartMate II continuous flow LVAD (134 patients). The median age was 64 years (range, 26-81) and the primary end-point was at two-years, survival free from disabling stroke and reoperation. Thirty-eight centers in the US participated in the study, led by Duke University and the University of Louisville.

Results of the study showed that patients implanted with the HeartMate II experienced less frequent adverse events and device replacements, and had a better quality of life and functional capacity. Two-year survival rate more than doubled among the HeartMate II patients. Specifically, after one year, 68 percent of those with the HeartMate II implanted were still alive, compared with 55 percent of those who received the older LVAD. At two years, results were more dramatic with 58 percent of those who received the HeartMate II were still alive, compared with 24 percent of those implanted with the older LVAD. Forty-six percent of patients (at the two year primary end point) were still alive, had not suffered a stroke, and did not need to have the device replaced, compared with 11 percent who received the older LVAD. The overall quality of life for patients with the HeartMate II improved, exemplified by the fact that they were able to walk double the distance that patients with older LVADs could.

HeartMate II LVAS Pivotal Study
The most recent outcomes for mechanical circulatory support therapy are from the HeartMate II LVAS Pivotal Study. The pilot trial for the HeartMate II LVAS began in November 2003 and consisted of 46 study patients at 15 centers.

The HeartMate II Pivotal Study began in 2005 and included the evaluation of HeartMate II for two indications: Bridge to Transplantation (BTT) and Destination Therapy (DT), or long-term, permanent support. It was the first time the FDA had approved a clinical trial to include both indications in one protocol. The HeartMate II Pivotal Study is the largest study of VADs ever conducted, with more than 1,000 patients who have been implanted with the device. In total, more than 3,000 patients have received the device both in the clinical trial and since its commercial availability for BTT, following FDA approval in April 2008. The FDA approval of HeartMate II for BTT was based on one year follow-up data from the first 194 patients enrolled in the trial. Clinical evidence supports positive survival outcomes and improved quality of life for a broad range of patients.

Eighteen-month follow up data on 281 patients who had either reached the study end-point or completed 18 months of post-operative follow-up showed improved survival, less frequent adverse events and greater reliability with continuous flow LVADS compared to pulsatile flow devices. Of the 281 patients, 157 patients had undergone transplant, 58 patients were continuing with LVADs in their body and seven patients had the LVAD removed because their heart recovered; the remaining 56 had died. The results showed that the NYHA Class of heart failure the patients had been designated had significantly improved after six months of LVAD support compared to the pre-LVAD baseline. Although this trial involved bridge to transplantation indication, the results provide early evidence that continuous flow LVADs have advantages in terms of durability and reliability for patients receiving mechanical support for destination therapy.

REMATCH
The REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) clinical trial began in May 1998 and ran through July 2001 in 20 cardiac transplant centers around the country. This landmark trial was designed to compare long-term implantation of left ventricular assist devices with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation. As a result of the clinical outcomes, the device received FDA approval for both indications, in 2001 and 2003, respectively.

The trial demonstrated an 81% improvement in two-year survival among patients receiving HeartMate XVE versus optimal medical management. In addition, a Destination Therapy study following the REMATCH trial demonstrated an additional 17% improvement (61% vs. 52%) in one-year survival of patients receiving the HeartMate XVE, with an implication for the appropriate selection of candidates and timing of VAD implantation.

A test carried out in 2001 by Dr. Eric Rose and REMATCH study group using patients with Congestive Heart Failure who were ineligible for a transplant showed a survival at two years of 23% for those implanted with an LVAD compared with 8% for those who were given drug treatment. The two major complications of VAD implantation were infection and mechanical failure.

According to a retrospective cohort study comparing patients treated with a left ventricular assist device versus inotrope therapy while awaiting heart transplantation, the group treated with LVAD had improved clinical and metabolic function at the time of transplant with better blood pressure, sodium, blood urea nitrogen, and creatinine. After transplant, 57.7% of the inotrope group had renal failure versus 16.6% in the LVAD group; 31.6% of the inotrope group had right heart failure versus 5.6% in the LVAD group; and event-free survival was 15.8% in the inotrope group versus 55.6% in the LVAD group.

HARPS Study
The Harefield Recovery Protocol Study (HARPS) is a clinical trial to evaluate whether advanced heart failure patients requiring VAD support can recover sufficient myocardial function to allow device removal (explantation). HARPS combines the HeartMate XVE with conventional oral heart failure medications, followed by the novel β2 agonist clenbuterol. This allows investigators to examine a strategy that may have enormous benefit for advanced heart failure patients: being able to forgo heart transplantation.

Birk's results showed that 11 of the 15 patients (73%) who underwent the combination therapy regimen exhibited adequate recovery to provide for explantation while avoiding transplantation. Surviving patients were 100% free from recurrent heart failure after one year and 89% free of recurrent heart failure after four years. The average ejection fraction was 64% at 59 months after explantation. Clenbuterol therapy produced no significant adverse effects.

ROADMAP Study
ROADMAP (Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients) is a prospective, multi-center, non-randomized, controlled, observational study to evaluate the effectiveness of the HeartMate II Left Ventricular Assist System (LVAS) versus Optimal Medical Management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HeartMate II LVAD destination therapy. The study, which aims to enroll 200 patients between October 2011 and December 2015, has an expected completion date of December 2015. The primary outcome measure is to find a composite of survival with improvement in a Six Minute Hallway Walk Test with a baseline distance of 75 meters or above.

Secondary outcome measures will look to analyze the accuracy of prognostic survival risk models including the Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS). They will also work to analyze patient quality of life, the rates of survival in the LVAD group without pump replacement, incidence of adverse events (like rehospitalizations), occurrence of depression, and more.

REVIVE-IT
In March 2013, Thoratec and the University of Michigan announced the REVIVE-IT trial. The study will enroll 100 patients from centers throughout the United States to assess the use of the HeartMate II earlier in the treatment of heart failure. The study, coordinated by the Michigan Institute for Clinical and Health Research, will test the theory that patients with advanced heart failure whose condition impairs their daily lives, but who have not suffered serious consequences such as organ damage, malnourishment, or immobility, would benefit from earlier implantation of an LVAD.

Corporate governance
The corporate structure of Thoratec has undergone many changes over the years. Currently, the company has three "corporate executives" and a nine-member board of directors.

Thoratec Corporate Executives

 * Gary F. Burbach (President and Chief Executive Officer)
 * Taylor Harris (Vice President and Chief Financial Officer)
 * David A. Lehman (Senior Vice President and General Counsel)

Thoratec Board of Directors

 * Steven H. Collis (President and Chief Executive Officer, AmerisourceBergen Corporation, Valley Forge, Pennsylvania)
 * D. Keith Grossman (President and Chief Executive Officer Conceptus Inc., Mountain View, California)
 * William A. Hawkins, III (President and Chief Executive Officer Immucor, Inc., Norcross, Georgia)
 * Paul A. LaViolette (Partner, SV Life Sciences, Boston, Massachusetts)
 * Daniel M. Mulvena (Founder and Owner, Commodore Associates, Wilmington, Delaware)
 * Todd Schermerhorn (Chief Financial Officer (retired) CR Bard, Mendham, New Jersey)
 * Neil F. Dimick (Chairman of the Board, Executive Vice President and Chief Financial Officer (retired), AmerisourceBergen Corporation, Laguna Hills, California)
 * Gary F. Burbach (President, CEO, Thoratec Corporation)
 * J. Daniel Cole (General Partner, Spray Venture Fund, Boston, Massachusetts)