Continuing its policy of little fuss and less fanfare, Abiomed (Danvers, Massachusetts) reported two more implants of its AbioCor artificial heart, in late September and mid-October, without releasing many details about the procedures or the patients. The latest implants are the third and fourth in the company's five-implant enrollment of the trial approved by the FDA. While the first two implants were performed at Jewish Hospital (Louisville, Kentucky), the latest were carried out at two other heart centers: The third implant was performed Sept. 27 at St. Luke's Episcopal Hospital (Houston, Texas), home of the Texas Heart Institute, and the fourth on Oct. 18 at the UCLA Medical Center (Westwood, California).
The implant procedure at St. Luke's was carried out by a team led by Dr. O.H. (Bud) Frazier, who had been present in the operating room during the second Jewish Hospital procedure, Abiomed said. St. Luke's was established in 1954 by the Episcopal Diocese of Texas, and the Texas Heart Institute was founded there by famed cardiovascular surgeon Denton Cooley in 1962, specifically for the study and treatment of disease of the heart and blood vessels.
The third procedure came on the heels of a statement concerning the condition of the first two implanted patients, Bob Tools and Tom Christerson. Both men, that statement said, had been doing well enough to receive guests. At presstime, Tools had been living nearly four months sustained by the AbioCor, and he was "gaining weight and enjoying excursions outside the hospital," according to his surgeons.
The fourth implant, at the UCLA Medical Center, was carried out, according to a press statement from Abiomed, in an 11-hour procedure by cardiothoracic surgeons Hillel Laks and Daniel Marelli and cardiologist Jaime Moriguchi, the principal investigators of the medical center's trial team. Laks, professor and chief of cardiothoracic surgery at UCLA's School of Medicine and director of the facility's heart, lung and heart-lung transplant program, described the implant procedure as having taken place "exceptionally well" and that the AbioCor device was "functioning beautifully."
Except for describing the latest AbioCor recipient as "a man in his 70s," and saying he was "resting comfortably," Abiomed and the medical centers continue the policy of withholding additional details in order to protect patient privacy and to maintain focus on clinical care. According to the few reports issued thus far, the first three AbioCor recipients all were making progress in their rehabilitation. All required initial ventilation and had some minor problems with internal bleeding, but they have been described as showing improved health.
In the latest statement, the UCLA Medical Center's heart transplant program is described as "one of the largest in the world, having performed more than 1,100 heart transplants since the program began in 1984." Laks founded the UCLA Alternate Recipient Heart Transplant Program in 1992 and was the first U.S. cardiac surgeon to perform bypass surgery on a donor heart prior to transplantation.
In Europe, the North Rhine-Westphalia Heart Center (Bad Oeynhausen, Germany) has been identified by Abiomed as the first site where an implant of an AbioCor will take place in that region, with the European trial set to begin within the next six months.
Medtronic laying off 450
Medtronic (Minneapolis, Minnesota) said in late October that it will lay off 450 workers at its Medtronic/AVE plant in Santa Rosa, California, those cutbacks forced by a court ruling that resulted in halting sales of its rapid-exchange balloon catheters and stent delivery products in the U.S. The company in September was forced to halt U.S. sales of a number of its products using the rapid-exchange system after a U.S. district court in California upheld the earlier ruling of an arbitration panel saying that the company had infringed upon patents held by Boston Scientific. The court also upheld the panel ruling requiring Medtronic to pay Boston Scientific (Natick, Massachusetts) $169 million for the infringement.
A spokesperson for the company said that it had to cut back on those hired to manufacture the stent products. She emphasized that the layoffs were the result of the court decision and had nothing to do with the current economic slowdown or the overall performance of the company and that there will be no changes in its quarterly report expectations.
In the patent litigation, Medtronic had argued that it had acquired the right to use the rapid-exchange system through its acquisition of the angioplasty business of C.R. Bard (Murray Hill, New Jersey). The court rulings did not impact its other stent product sales, and the company can continue selling the rapid-exchange products outside the U.S.
News of new grants
Kensey Nash (Exton, Pennsylvania) reported receiving a $1.9 million award through the National Institute of Standards and Technology ATP program for a three-year effort to develop a synthetic small diameter vascular graft. In collaboration with the Washington University School of Medicine (St. Louis, Missouri) and the Armed Forces Institute of Pathology (Washington), the company will research and develop a 3-D porous scaffold composed of multiple biomaterials designed to mimic the appropriate biomechanical properties of a natural vessel with the intent to ultimately regenerate a functioning artery. The award is structured to support this program over a three-year period. The project is based on an advanced technology platform under development at Kensey Nash enabling the integration of biomaterials and biologically active agents into a single tissue-engineered devices which can be designed to imitate the physiological characteristics of tissue providing a platform for arterial regeneration. Kensey Nash is also in the second year of a three-year $1.2 million ATP grant project to develop an implant for articular cartilage repair and regeneration.
Progenics Pharmaceuticals (Tarrytown, New York) received about $300,000 from the National Institutes of Health (Bethesda, Maryland) as a Phase I Small Business Innovation Research grant. The grant is for the development of dehydroascorbic acid (DHA) as a therapy for ischemic stroke and will support preclinical efficacy studies, early manufacturing scale-up and formulation development. Also, the company said that an article in the Proceedings of the National Academy of Sciences described how DHA decreased brain damage and neurological deficits when administered up to three hours after a stroke in an animal model.