Medical Device Daily Associate

After nearly a decade of development and millions of dollars invested, Arrow International (Reading, Pennsylvania) reported yesterday that it plans to discontinue its LionHeart left ventricular assist system (LVAS) program and focus its resources on what it believes is a more promising product, its CoreAide continuous flow, ventricular assist device (VAD).

The company said that after carefully considering a wide range of medical, patient care and economic factors, its board unanimously voted to discontinue the development, sales and marketing programs related to the LionHeart.

Earlier announcements issued by the company may have signaled that the LionHeart program was headed for an early retirement. The company reported in April 2004 that it was deferring its U.S. Phase II clinical trial (Medical Device Daily, April 16, 2004), saying at the time that it preferred to see how the next generation of the device would fare in the European market, where it received CE-marking in November 2003. The newer device has a smaller battery and other system enhancements.

The company originally received the FDA's approval of an investigational device exemption for a Phase I trial of the system more than three years ago, in early 2001 (MDD, Feb. 12, 2001).

While Carl Anderson Jr., company chairman and CEO, in a statement said that the LionHeart program established "a new level of technological achievement," which included winning the CE mark, the company concluded that continuing the LionHeart program was just not economically feasible.

Anderson noted that the company had "thoroughly assessed the significant additional time and investment required to maximize the potential of the LionHeart. Based on careful consideration of all of these factors, we have determined that the LionHeart is not economically viable for Arrow, as it would not realize adequate returns for Arrow shareholders in an acceptable period of time."

"We have reviewed ventricular assist technology trends, considered our experience marketing the device in Europe, the input we received from the medical community, as well as the data and analysis of the outside consultants we retained to analyze the long-term commercial opportunity of this program," he said.

He added that the company was still "fully committed" to providing the necessary ongoing technical and clinical support for the one patient who is currently implanted with the device.

Arrow has decided that it will continue the clinical trial of its CorAide continuous flow ventricular assist device in Europe.

The company acquired the right to develop the CorAide via a licensing agreement with the Cleveland Clinic Foundation (CCF; Cleveland) 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).

Arrow said that it believes the CorAide's smaller size, less-invasive surgical approach and inherently simpler design offers better opportunities for broader market acceptance.

In February, CorAide devices were implanted in two patients in Bad Oyenhausen, Germany in conjunction with the company's clinical trial. As Arrow reported on March 21, both patients continue to recover as expected.

Similar to the Debakey VAD from competitor MicroMed (Houston, Texas), the CorAide is non-pulsatile and features a magnetically suspended pumping mechanism and uses the moving blood as its lubricating system.

Based upon its decision to abandon the LVAS work, the company will write off in the second fiscal quarter, ended Feb. 28, 2005, its remaining investment in LionHeart, which includes $2.8 million in manufacturing equipment and components. The write-off will be included in the company's unaudited financial statements reported in its Form 10-Q for the second quarter of FY05, scheduled to be filed April 11.

Aside from MicroMed, other competitors involved in the VAD sector include A-Med Systems (West Sacramento, California), Thoratec (Pleasanton, California), WorldHeart (Oakland, California), Vascor (Pittsburgh) and VentraCor (Sydney, Australia).

Abbott's ZoMaxx gets conditional IDE

Abbott Vascular (Redwood City, California), a division of Abbott Laboratories (Abbott Park, Illinois), said it has received conditional approval from the FDA for its investigational device exemption (IDE) application for the ZoMaxx drug-eluting stent (DES).

As a result, Abbott reported that it soon will begin enrolling the first 250 patients into its ZOMAXX II drug-eluting coronary stent clinical trial in the U.S. Launch of enrollment into the trial is consistent with anticipated U.S. approval for ZoMaxx in the second half of 2007, the company said.

The ZOMAXX II trial will enroll 1,670 coronary artery disease patients at up to 80 centers. The trial will compare clinical outcomes in patients who are treated with Abbott's investigational ZoMaxx DES with patients who receive Boston Scientific's (Natick, Massachusetts) Taxus Express2 DES.

The primary endpoint of ZOMAXX II is nine-month, ischemia-driven, target vessel revascularization, a clinical measure of the need to conduct another intervention (such as stent, brachytherapy or surgery) to reopen a vessel previously treated with a stent.

"Abbott is committed to develop the ZoMaxx drug-eluting stent as an important new treatment for coronary artery disease patients worldwide," said Robert Hance, president of Abbott Vascular. "The ZoMaxx drug-eluting stent is poised to become an important product in Abbott Vascular's growing line of vessel closure, coronary and endovascular products."

Outside of the U.S., Abbott continues to enroll patients in ZOMAXX I, a 400-patient prospective randomized clinical trial that is being conducted in more than 30 centers in Europe, Australia and New Zealand. ZOMAXX I also compares Abbott's ZoMaxx stent to Boston Scientific's Taxus stent.

The ZoMaxx DES consists of three key components: a flexible stent platform called TriMaxx, designed to facilitate ease of placement; a polymer-carrier called Pharmacoat, intended to enable steady drug elution; and Abbott's immunosuppressant drug called ABT-578, shown to reduce vessel re-narrowing.

ABT-578 is in the same family as rapamycin, used by Cordis (Miami Lakes, Florida) in its DES program, as well as Guidant's (Indianapolis) everolimus compound.

Interestingly, ABT-578 is being licensed to Medtronic (Minneapolis) for its own DES program. Both Medtronic and Abbott use the Pharmacoat stent coating. Additionally, the Abbott device incorporates a balloon and catheter delivery system from Medtronic into its platform.