In a webcast conference call last month, replacement heart manufacturer Abiomed (Danvers, Massachusetts) provided a sketchy overview of its current activities, with that overview tending to underline at least two critical points for the company:
First, that Abiomed's clinical trial of the AbioCor artificial replacement heart is on track, and company executives are still pointing for FDA clearance of the product some time in 2004.
And secondly, that the company has the goal of being the only firm in the heart pump assistance market to offer products that serve the entire sector.
The update of the AbioCor trial was less than highly detailed, with David Lederman, PhD, Abiomed's chief executive officer, answering questions numbering only about half a dozen submitted before the call and providing virtually no new clinical insights. He reported 11 patients thus far enrolled in the trial, with nine surviving the operation. To date, just one of the nine remains alive.
Overall, the AbioCor patients have lived for periods of two months to 17 months supported by the device, with the average length of time nearly six months. That figure approximately triples the time of 60 days that has been set as the successful endpoint of the trial for providing additional life to the enrolled patients, those enrollees generally given from just a few days to only about a month more to live to qualify for implantation.
Lederman gave no indication as to the timeline for the additional implants in the 15-patient trial approved by the FDA, but he said that the company is aggressively focused on reviewing the trial's current position "from the clinical perspective of an enormous body of data." He said that the company's current top priority is the investment of "a high level of energy and attention over the next several weeks" to complete the final enrollments in the trial and that the company as a whole is "energized, optimistic."
He noted that the company is continuing to work on device improvements that at some point will result in a second-generation AbioCor device.
The remainder of the conference call, handled by Ed Berger, PhD, Abiomed's vice president for strategic planning and policy, focused on analyzing the heart disease and congestive heart failure markets targeted by the company. He broke the market down into five segments: bridge to recovery, bridge to transplant, bridge to other therapies, permanent replacement and permanent assistance.
Abiomed's BVS5000 circulatory assist device recently further augmented and supported by clearance of the AB5000 Circulatory Support System console in early May addresses the first three of these segments, and the AbioCor addresses the permanent replacement segment. Thus the company has a product line that "gives Abiomed solid footing across 70% of the total [heart assist] device marketplace, with clear leadership in the bridge to recovery and permanent heart replacement segments," Berger said. The remaining 30% the permanent assistance sector describes that group of patients that could benefit from ventricular assist devices (VADs), and Berger emphasized the company's previously stated commitment to be a strong player in this area as well, thus covering every segment of the available patient pool.
The company does not yet have a cleared product in the VAD market, though Berger noted that one product in this category is currently under review by the FDA. "We are committed to being active in that marketplace when the timing and technology are right," he said. "We're looking very carefully to enter that market segment in the strongest possible way."
Dispute panel meeting cancelled
CardioGenesis (Foothill Ranch, California), a developer of transmyocardial revascularization (TMR) and percutaneous myocardial revascularization (PMR) technologies, said last month that its scheduled Aug. 20 meeting with the FDA's Medical Device Dispute Resolution Panel (MDDRP) has been cancelled, based upon a decision by CardioGenesis and the FDA that the agency will review additional data to be submitted by the company in support of its premarket approval supplement for the PMR system.
Michael Quinn, chairman and chief executive officer of CardioGenesis, said that the company and the FDA "have agreed to work interactively to attempt to settle the scientific dispute in connection with the company's pending PMA supplement for its PMR system without the need for a MDDRP hearing." He said the decision to defer the dispute resolution hearing is based on discussions with FDA management from the Center for Devices and Radiological Health and Office of Device Evaluation (ODE).
CardioGenesis said that it would submit additional information to the ODE, "which has committed to a rapid, interactive review with the company." Quinn added that he is optimistic "that the additional information can resolve the dispute without the need for a hearing." He said, "We are encouraged by the commitment of the FDA to work interactively with us on their review of the additional information, which we are hopeful will be adequate to address the concerns of the FDA and support an approval decision. Their firm commitment to a rapid review and consideration of the additional information were the key factors in our decision to defer a hearing before the MDDRP."
1st implant of Australian 'artificial heart'
Ventracor (Sydney, Australia) last month reported the first implantation of its VentrAssist left ventricular assist system (LVAS) being billed as the "Australian artificial heart" as it launched its 10-patient pilot clinical trial of the device. The VentrAssist was implanted in a person described as "an older man with end-stage congestive heart failure" at The Alfred Hospital (Melbourne, Australia).
Professor Don Esmore, the chief medical investigator for the trial, said that the medical team planned to monitor the first patient for six to 10 weeks before performing a second implantation. Additional patients then will be enrolled "on a more timely basis," the company said in a statement.
The VentrAssist VAS is a centrifugal blood pump designed to provide permanent left heart support and is powered by a set of wearable batteries that last about eight hours before they need to be recharged. It uses a hydrodynamically suspended rotor and has no valves, seals, shafts or bearings, therefore reducing the possibility of creating wear via friction or producing blood damage.