In a move based primarily on clinical data, Abbott Laboratories (Abbott Park, Illinois) last month reported that it was scrapping its ZoMaxx drug-eluting stent (DES) program and launching the Xience V DES system. Abbott said that the Xience V, an everolimus-eluting DES, will be introduced immediately in the majority of European countries, and it will focus its commercial, manufacturing and clinical resources exclusively on the Xience V. The company said that the decisions were based on the data from its clinical trials.

“We have conducted a thorough analysis of all available clinical data for both Xience V and ZoMaxx, and have concluded that Xience V is a significantly better product,” said Richard Gonzalez, president and chief operating officer of Abbott. “Following encouraging physician feedback from our prelaunch evaluation program in Europe, and given the positive Xience V data, we remain confident in our ability to achieve a leadership position in the drug-eluting stent market with the Xience V platform.”

Abbott’s move to scrap its ZoMaxx program —described as homegrown — was also seen as fallout from its acquisition of the Xience V product from Guidant (Indianapolis) after that company was acquired by Boston Scientific (Natick, Massachusetts) earlier this year as part of a Federal Trade Commission-mandated divestiture. The ZoMaxx system was made up in part of polymer coating technology acquired when Abbott purchased Biocompatibles International’s (Basingstoke, UK) cardiovascular stent business for $245 million in 2002. The device utilized zotralimus, a drug developed in-house by Abbott.

Melissa Brotz, an Abbott spokesperson, told Cardiovascular Device Update that Xience V “has clearly superior clinical results. It is clearly the stronger platform that will offer the greatest benefits to patients. Once you look at the data and saw the clinical performance of both, then it made sense to us to focus the resources on one [system].”

That conclusion was backed by Larry Biegelsen, med-tech analyst with Prudential (New York), who in a report said, “It appears that the ZoMaxx data is inferior to that of Xience V.” And JP Morgan analyst Michael Weinstein wrote in a report that the implications for Abbott were slightly negative. “Abbott goes from having two horses to ride in this race to one,” he said. Weinstein added that the Abbott news also may have implications for stents made by Medtronic (Minneapolis), which uses zotarolimus, through a technology-swapping deal the companies cut in 2002. Abbott’s decision to drop ZoMaxx, however, assures that Medtronic would be the only company to launch a DES using the drug zotarolimus, eliminating the “risk that Abbott leapfrogs Medtronic with a similar, but better product,” Weinstein said.

A loser in all of this would appear to be Biocompatbles. In its agreement with Abbott, the company stood to gain royalties in the range of 1%-5% on DES devices sold by Abbott containing its polymer coating technology. Biocompatibles was expecting to start receiving royalties in the second half of 2007, but it said that the news will not hurt it — at least in the short run. “Abbott’s announcement has limited impact on 2006 and 2007 sales and no impact on cash in either year,” Biocompatibles said in a press release. “Commercialization of drug-eluting bead products remains the company’s principal focus,” it added.

Abbott said the European launch of Xience V came three weeks earlier than expected. Originally, the company had predicted a second-quarter launch of the X stent in Europe but pushed that back to the third quarter after finding some products with quality problems.

Biophan pushes Myo-Vad via $7.25 million

A $7.25 million investment in Biophan Technologies (Rochester, New York) from a group of institutional investors will help move the Myotech Myo-Vad closer to development. The investment was made as a private placement. Biophan said it will use the money to move the Myotech Myo-Vad — now in preclinical study — into the clinical trial stage sometime in 2007, Carolyn Hotchkiss, a spokeswoman for Biophan, told CDU.

The Myo-Vad is a new MRI-compatible cardiac recovery system intended to improve treatment of various forms of heart disease. It consists of a flexible polymer cup that can be installed around the heart in about three minutes, unlike traditional ventricular assist devices (VADs) that take 45 minutes to two hours to install with major surgery, according to Biophan. The device operates by compressing and expanding, providing the energy that allows the heart to restore the blood flow to normal. Myo-Vad is also designed to eliminate most of the common complications associated with VADs such as clotting, stroking, bleeding and infection since it does not contact circulating blood.

Some of the $7.25 million investment may also help Biophan continue to develop its MRI-safe and image-compatible technologies for pacemakers, implantable defibrillators, neurostimulators and other devices.

Biophan will issue $7.25 million in senior secured convertible notes, which will be repaid in 33 monthly payments. The notes are convertible into common shares at a conversion price of 67 cents a share, with principal and interest payable between 10% and 12% per year. The investors will receive warrants equal to the amount of shares into which the notes may be converted, with 50% exercisable at $0.89. Investors were given the option to purchase another $7.25 million of common stock at a price of 67 cents a share, with warrants for 50% of the amount of shares issued exercisable at 115% of the share price.

Biophan makes products that enable medical systems such as pacemakers, catheters, guidewires, and implants to be safely imaged under MRI. The company holds 42% interest in Myotech (West Henrietta, New York) and has distribution rights to the Myo-Vad.

Medtronic gets warning for AneuRX filing delay

Medtronic (Minneapolis) received an FDA warning letter last month regarding the delayed filing of a postmarket surveillance interim report concerning its AneuRx stent graft system, used to treat abdominal aortic aneurysms (AAA). The company said it has been working with the FDA to submit the interim report in a manner that will meet its requirements. It said the warning letter is not related to the quality, design or manufacture of the AneuRx product, approved by the FDA in 1999.

The interim postmarket surveillance report is a routine filing and has been issued annually since 2002 by Medtronic to report the results of a postmarket approval study of patients with the AneuRx stent graft system. The company said that the approval study, begun in 2002, was undertaken to make sure the AneuRx device is appropriately labeled for use in carefully defined patient populations for which the risk/benefit profile is known to be favorable, and to confirm the necessary training and experience for users of the AneuRx device.

The device has a proven safety record and is among the most implanted AAA devices on the market, the company said, and that it “looks forward to a prompt resolution of the matter with the FDA.”

St. Jude reports pacemaker software ‘bug’

St. Jude Medical (St. Paul, Minnesota) last month reported that it has discovered a glitch in the computer software used to drive two of its programmers for the Identity series of pacemakers and that it was developing a patch for the problem. The software used in the APS III models 3500 and 3510 and the Merlin PCS 3650 pacemaker programmers are subject to “an anomaly in the programmer’s software [that] may lead to incorrect reporting of battery voltage, expected battery longevity and elective replacement indicator status,” the company said in a statement.

These units are used to program three of the company’s Identity series pacemakers, the SR 5172, the DR 5370 and the XL DR 5376. The software versions affected are 6.1.1 and earlier for the APS units and 4.1.1 and earlier for the Merlins. The company said it expects to have the corrected software available “within two months, pending regulatory approval.”

Angie Craig, St. Jude’s VP of corporate relations, told CDU that the firm has performed its own validation of the software fix and is awaiting agency review. She added that the two-month figure is an estimate of how long the FDA might need to review the validation documents.

The company’s physician letter stresses that this problem affects “only the reporting of these measured data parameters” and that “functionality, actual longevity and battery status are not affected.” The letter also states that the company has not received any reports of adverse events in connection with the software problem, which is said to have demonstrated an incidence rate of 0.027%, or 53 field reports out of more than 199,000 devices.

According to a separate document titled “physician device advisory notice,” the software can cause the programmer to write unspecified data to “a location in an Identity pacemaker’s memory that could, under certain rare device timing conditions, have the effect of preventing the automatic daily update of internal battery status.” The advisory notes further that because this daily calculation mechanism also adjusts “the magnet rate,” any attempts at trans-telephonic monitoring may prove futile.

CryoCor delays PMA amendment filing for AFL

CryoCor (San Diego), focused on the treatment of cardiac arrhythmias, reported a delay for filing an amendment to its premarket approval application for the treatment of atrial flutter (AFL). CryoCor expects the amendment to be filed with the FDA by the end of November.

Ed Brennan, president/CEO of CryoCor, said, “This is an important filing for CryoCor, and we have thoroughly reviewed the safety and effectiveness data from our AFL pivotal study. We believe the additional time will allow us to provide supplementary information to these data. We will be presenting our strongest case and look forward to working with the FDA in seeking approval for the treatment of AFL with our system.”

CryoCor manufactures a disposable catheter system based on its cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The company’s product, the CryoCor Cardiac Cryoablation System, or the Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue.

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