A Medical Device Daily

WorldHeart (Oakland, California) had a string of financial difficulties last year, but that hasn't stopped the company from moving forward with the development of its Levacor Ventricular Assist Device (VAD), intended for bridge-to-transplant (BTT) use in cardiac transplant candidates with presumed non-reversible left ventricular failure.

The company last week said that it has submitted an Investigational Device Exemption application to the FDA for a pivotal BTT study of the Levacor VAD. The proposed primary endpoints of the study include survival to heart transplantation, explant for myocardial recovery, or survival to 180 days supported by the device.

According to the company, the IDE application includes detailed device information, including design and in vitro and in vivo preclinical testing protocols and results. The submission also includes an investigational plan and extensive study-related materials, WorldHeart noted.

"This IDE submission marks an important milestone for WorldHeart," said Jal Jassawalla, president/CEO of WorldHeart. "We look forward to the FDA's initial review of this submission and will answer, in supplemental submissions, any agency questions or requests. We are eager to progress to the clinical study stage in collaboration with many key clinicians in this field who have expressed a strong interest in participating."

WorldHeart says that the Levacor VAD, a fourth-generation rotary VAD, is a bearingless, magnetically levitated implantable centrifugal rotary pump. In contrast to second- and third-generation pumps with blood-immersed mechanical or hydrodynamic bearings, the Levacor uses full magnetic levitation to suspend the spinning rotor, in order to eliminate wear within the pump and allowing greater clearances around the rotor for blood flow, WorldHeart said.

Last year WorldHeart learned that its potential primary investor from an equity financing would not be able to meet its commitments. As a result, the company was not able to pay back a secured convertible promissory note in the amount of $5 million issued in December 2007 to Abiomed (Danvers, Massachusetts).

Abiomed later agreed to convert the $5 million debt to 86 million shares and, as a result, now owns a 21.6% stake in WorldHeart (Medical Device Daily, Aug. 5, 2008).

Then, in late August, WorldHeart reported that it would embark on a phased consolidation into a primary facility at its Salt Lake City facility. The company said at the time its focus is on the development, clinical trial, and subsequent commercialization of the Levacor VAD.

The company first eliminated five positions, including the VP of manufacturing at its Oakland facility, held by John Vajda. It said a second consolidation phase would include the elimination of 10 additional Oakland positions and the relocation of other positions to Salt Lake City.

The consolidation plans also include a search for a CEO to reside in Salt Lake while Jassawalla stays in California in a senior management position (MDD, Aug. 22, 2008).

In December 2007, when Abiomed agreed to loan WorldHeart the $5 million secured debt, the companies also entered into a two-year marketing and clinical support services agreement to seek opportunities to leverage existing expertise and resources of Abiomed and potentially provide it significant cost savings (MDD, Dec. 13, 2007).

The companies said they planned to explore "technical synergies," such as the potential to use Abiomed's information and transcutaneous energy transfer (iTET) system with WorldHeart's Levacor product. Abiomed's iTET system consists of internal and external coils that are used to transmit power and information across the skin.