| Type | Public (NASDAQ: THOR) |
|---|---|
| Industry | Medical devices |
| Founded | California, U.S.(March 1, 1976) |
| Headquarters | Pleasanton, California |
| Area served | Global |
| Key people | Gary F. Burbach President and CEO David V. Smith CFO |
| Products | HeartMate XVE HeartMate II |
| Revenue | USD (million) 313 (2008) |
| Operating income | USD (million) 26 (2008) |
| Employees | 1,110 |
| Divisions | ITC |
| Website | Thoratec.com |
Thoratec Corporation is a United States-based company that 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. Headquartered in Pleasanton, California, U.S.A., its product lines include the Thoratec VAD (Ventricular Assist Device) and HeartMate LVAS (Left Ventricular Assist System). Thoratec’s devices are implanted in patients with advanced heart failure worldwide.[1]
Thoratec’s division, International Technidyne Corporation (ITC) supplies blood testing and skin incision products[2].
For patients with acute heart failure, Thoratec markets the CentriMag Blood Pumping System, which is manufactured by Levitronix LLC and distributed by Thoratec in the U.S. under a distribution agreement with Levitronix.
Thoratec’s shares were listed on NASDAQ on May 18, 1981.
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Thoratec Corporation was incorporated in California in March 1976 under the name Thoratec Laboratories Corporation. The name was changed to Thoratec Corporation in 2001 at the time of a merger with Thermo Cardiosystems, Inc., a manufacturer of cardiac assist, blood coagulation testing, and skin incision devices. The merger was completed on February 14, 2001.
Thoratec’s cardiovascular division VAD products primarily serve patients suffering from late-stage heart failure. In the United States[3][4]:
For most patients, heart transplantation is the most effective treatment for survival. However only 2,100 advanced-stage heart failure patients receive heart transplants while some 250,000 have to explore other treatment options. Mechanical circulatory support (MCS) with a ventricular assist device (VAD) is used to boost hemodynamic function in hearts and is a suitable option for patients as a bridge to transplantation support device[5][6].
While surgery is not a frequently used treatment, it is a necessary treatment for certain patients who cannot be helped with medication or dietary and lifestyle changes.
In a small number of cases left ventricular assist devices, combined with drug therapy, have enabled the patient’s heart to recover sufficiently for the device to be able to be removed (explanted)[7].
Thoratec works directly with cardiologists, surgeons and VAD coordinators in a variety of ways, from building community awareness and developing education materials regarding MCS therapy, to providing training and patient support. Thoratec offers educational and charitable grants for advancing MCS therapy as well.
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.[8]
In July 2009, the Journal of the American College of Cardiology reported on 18-month follow-up data for the HeartMate II LVAS Pivotal Study, which showed improved survival, less frequent adverse events and greater reliability with continuous flow LVADS compared to pulsatile flow devices.[14]
The HeartMate family of devices illustrates a continuum of technological upgrades in the VAD market:
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.[15]
Results included the following:[16][17]
The study concluded that treatment for the destination therapy indication with the HeartMate II significantly improved the probability of survival free from stroke and device failure at two years.
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.[18]
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.[18]
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.[18]
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.[18]
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.[18]
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.[19]
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.[19]
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.[19]
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.[19]
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.[20]
Birk's results to date:[20]
Thoratec Corporation has two operating divisions: Cardiovascular and International Technidyne Corporation (ITC), its wholly owned subsidiary[2].
The Cardiovascular division develops, manufactures and markets proprietary medical devices used for MCS for advanced heart failure. The Thoratec product line includes the PVAD and IVAD and the HeartMate product line includes the HeartMate XVE and HeartMate II. The Company also markets the CentriMag Blood Pumping System, manufactured by Levitronix. Thoratec also manufactures a vascular access graft for renal dialysis[2].
The ITC division develops, manufactures and markets two product lines: point-of-care diagnostic systems and incision products. The point-of-care diagnostic systems include test systems that monitor blood coagulation and systems that monitor blood gas/electrolytes, oxygenation and chemistry status for hospital and alternate site point-of-care. The incision products include devices used to obtain a patient’s blood sample for diagnostic testing and screening for platelet function[2].
Thoratec is focused on maintaining and expanding their leadership position. This includes offering a broad range of products, focusing on and partnering with leading heart centers, expanding the use of VADs in existing segments, increasing the Company’s presence in Cardiovascular and ITC segments, obtaining approval for and developing new products, and increasing the cost effectiveness of the therapies that employ Thoratec’s products[2].
Thoratec Corporation’s main executive officers are[2]:
The Company’s Board of Directors consists of nine members:
Thoratec is headquartered in Pleasanton, California, and has manufacturing facilities in Burlington, Massachusetts;Rancho Cordova, California; Edison, New Jersey; and Cambridgeshire, United Kingdom[2].
VADs and grafts for the Cardiovascular Division are manufactured at Thoratec’s Pleasanton headquarters.
In February 2001, Thoratec completed a merger with Thermo Cardiosystems Inc. (AMEX: TCA), a Massachusetts-based manufacturer of cardiac assist, blood coagulation testing, and skin incision devices. It was at the time of the merger that Thoratec changed its name from Thoratec Laboratories Corporation to Thoratec Corporation.
In February 2009, Thoratec entered into a merger agreement to acquire HeartWare International (Nasdaq: HTWR) in a transaction valued at approximately $282 million. On July 31, 2009, Thoratec and HeartWare announced the termination of the agreement, citing strong opposition from the Federal Trade Commission.
In January 2010, Thoratec acquires catheter-based heart pump technology from Getinge. Thoratec is expected to pay Getinge a cash purchase price of $8.5m for the technology, which is a minimally invasive, acute cardiac axial flow pump.[21]