Is there an Engineer in the House?
This article was originally published in Start Up
The recent clinical successes of artificial hearts and VADs knock over the first barrier to adoption of a new, life-saving therapy. But other hurdles remain, including providing the infrastructure to service large numbers of patients going about with extremely complicated, often quirky high-tech implantable devices on which their lives depend. The University of Pittsburgh is marshalling its bioengineering resources into a commercial entity, start-up Vital Engineering, which will be able to provide post-implant services on a wider, even global scale.
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The striking results of the REMATCH trial, demonstrating the efficacy of Thoratec's ventricular assist device to extend the life of terminal heart failure patients, is heartening clinicians and patients and opening up new markets for ventricular assist device manufacturers. Thoratec still faces FDA and reimbursement hurdles before its devices become long-term therapies in large volumes of patients. Meanwhile, the competition hopes to profit from the precedent-breaking REMATCH results, and overtake Thoratec's lead with claims of technological superiority in the long-term heart assist market.
Recently, all three major players in the ventricular assist device market have consolidated. In May of this year, Baxter International merged its Novacor VAD business into World Heart. Not long after, Thoratec Laboratories acquired the ThermoCardiosystems division of Thermo Electron. Each deal had a different primary motive, but the companies all share a common goal of positioning their businesses for a long and expensive development process.
A new generation of miniature, totally implantable devices for end-stage congestive heart failure promises to return patients to normal lives. If the implantable ventricular assist devices can function reliably for many years, they may offer patients an alternative to heart transplantation and even arrest the progression of the diseases at earlier stages.