Arrow International (Reading, Pennsylvania) said last month that it plans to defer a U.S. clinical trial of its current iteration of the LionHeart Left Ventricular Assist System (LVAS) for a destination therapy indication, saying it prefers to see how the next generation of the device, which has a smaller battery and other system enhancements, fares in the European market, where it was approved via a CE mark last November.
The company termed the postponement in the U.S. a "modification of its business strategy," saying it has decided to defer commencement of the LionHeart Phase II clinical trials, required to bring the product to market, until Arrow is able to implement product design enhancements currently being tested.
Earlier this year, Arrow initiated its marketing program in Europe and included the training of additional centers to implant the device, supplementing the centers already participating in the clinical trials. The company said its near-term focus in Europe continues to be on obtaining optimal clinical results and evaluating product enhancements currently in development. It noted that these enhancements "should increase the patient population for whom the device is suitable and provide improved quality of life for recipients."
"The LionHeart LVAS is a promising new technology," Chairman and Chief Executive Officer Carl Anderson Jr. said in a statement. "We intend to increase our current sales and marketing efforts for the device in Europe, but we will not proceed with the Phase II clinical trials in the U.S. at this time."
Anderson noted that given the significant additional time and costs involved and the current regulatory environment, "we will move forward in the U.S. only when we have assessed comprehensively the impact of our product design enhancements." He added that the company still expects to complete its ongoing Phase I pilot study of the U.S. trials, and is proceeding with the development of its sales and marketing program for the LionHeart in Europe and remains "fully focused on achieving excellent clinical outcomes there."
Arrow had previously reported that it expects revenue generation from initial sales of the LionHeart in Europe to be absorbed by marketing and clinical support costs, which are increasing, and will not contribute to earnings during fiscal year 2004. According to Frederick Hirt, the company's chief financial officer, Arrow made the decision on its own to defer the Phase II trial in the U.S., without any pressure from the FDA. "We're going to finish Phase I and then we're going to see how the [new] batteries work in Europe and make a definitive decision on Phase II later," he told Cardiovascular Device Update.
Hirt noted that the new battery is substantially smaller than the first-generation model, weighing about 1-1/2 pounds vs. 3 to 4 pounds for its predecessor. "It cuts the weight in half," he said. "It's much smaller [and] you can put it on a belt." He also said the new iteration of the LionHeart will have a new internal controller that is much smaller. "The old configuration was square because of the size of the batteries; the more elliptical shape that we're developing now will not pinch people when they're bending over and so forth, so it will be much more comfortable."
In conjunction with its decision not to commence the Phase II U.S. clinical trials at this time, the company is evaluating the possibility that certain LionHeart components may become obsolete with the introduction of the second-generation components. Any resulting accounting adjustment would be recorded in its fiscal third quarter ending May 31, Arrow said. The aggregate amount of LionHeart inventory on hand, net of allowances and purchase commitments as of Feb. 29, was $5.1 million and the potential accounting adjustment is not expected to exceed that amount.
The company said it also continues to develop and test modifications to its CorAide continuous flow ventricular assist device (VAD) to resolve elevated levels of hemolysis experienced in the first implant of the device. Arrow acquired the right to develop the CorAide via a licensing agreement with the Cleveland Clinic Foundation (CCF; Cleveland, Ohio) in April 2001. That agreement involved CCF's patents in the field of non-pulsatile centrifugal flow ventricular-assist devices for the treatment of congestive heart failure and a related agreement for continued research and development on the CorAide VAD that had been a joint development effort of CCF and the National Institutes of Health (Bethesda, Maryland).
Similar to the MicroMed (Houston, Texas) Debakey VAD, the CorAide device is non-pulsatile. It features a magnetically suspended flow pumping mechanism and uses the moving blood as its lubricating system.
While Arrow said there can be no absolute assurance that the modifications to the CorAide will resolve the problem, at this juncture Hirt said the company is "reasonably optimistic that suitable improvements have been developed to address the hemolysis issue." He also noted that Arrow believes that if trials are successful with that device, it may one day supplant the LionHeart as a destination therapy device, though it is currently not in trials in the U.S. for such an indication. Arrow said it expects that clinical trials of the CorAide device should resume later this year.