Boston Scientific (Natick, Massachusetts) hit a speed bump on its road to clearance of a drug-coated stent product, as the FDA last month failed to clear the design of its key TAXUS IV clinical trial. The company was seeking the okay of its trial using paclitaxel as a stent coating to prevent reclogging. Boston Scientific said it would seek approval from the FDA to begin the clinical trial later in the first quarter, asserting that this is a timeline basically allowing it to remain on track for launch of the product in late 2003.

The company filed its investigational device exemption (IDE) application for the trial last October but then in December reported that the FDA had asked it to answer various questions concerning the filing. At the time, the company had estimated that the setback would probably delay initiation of the trial until January or February, but the first enrollments are now delayed until March at the earliest.

Ongoing follow-up of patients in the TAXUS I trial, a 60-patient pivotal European pilot study, continues to report zero restenosis at nine months. In the TAXUS II trial, a 536-patient pivotal European trial, Boston Scientific has completed enrollment and expects to have six-month follow-up data on all patients by mid-2002. Finally, six-month angiographic data from the TAXUS III trial, a 30-patient European study of in-stent restenosis patients, is expected to be presented in March at the American College of Cardiology's (Bethesda, Maryland) annual conference in Atlanta, Georgia.

Kevin Kotler, med-tech analyst with ABN Amro (New York), said that because of the novelty of the drug-coated stent technology, the FDA has apparently become "more critical on the lack of supporting animal and human data than with prior trials, thus potentially forcing [Boston Scientific] to follow a simpler protocol."

David Gruber, MD, analyst with Lehman Brothers (New York), said that "clinical data rather than timing of the launch" will be the primary determinant of success in the coated-stent market.

Another company hit with potential delays in a drug-coated stent trial was Biocompatibles (Farnham, UK), which late last month received questions from the FDA concerning its BATMAN II trial. That trial is designed to evaluate the safety and efficacy of the Batimastat BiodivYsio stent, which combines Biocompatibles' proprietary drug-eluting stent technology with batimastat, an inhibitor of restenosis from British Biotech (Cambridge, England).

Biocompatibles said that it was working to resolve the issues raised by the questions but did not expect any delay of trial launch, set for the second quarter. The company filed its IDE for the trial Dec. 20. The trial is planned for enrollment at 40 centers in the U.S. and Canada. Batimastat is licensed to Biocompatibles by British Biotech, and BiodivYsio stents are distributed in the U.S. by Abbott Laboratories (Abbott Park, Illinois)

In a statement, the company said it "continues to recruit patients and remains on track" with its BRILLIANT II trial, intended to secure the European CE mark. BRILLIANT II is a 400-patient pivotal randomized trial to determine the clinical performance of the batimastat-loaded stent relative to a stent without the drug. It is to be conducted at centers in the UK, France, Belgium and Holland

Medtronic expands focus to IT

Medtronic (Minneapolis, Minnesota) has built a major franchise around systems implanted within the body. With that foundation, it is looking to expand that focus to ways in which information gathered by its implantable devices can be made more readily available outside the body, according to Chris O'Connell, vice president of Medtronic's patient management business. In a conference call last month, O'Connell reviewed the impact of recent developments for the company in terms of patient data gathering and handling and said that "clearly, the future is moving to information" in the health care environment.

Those developments were the FDA's end-of-year clearance of Medtronic's CareLink monitoring system, and the company's subsequent acquisition of the Paceart unit of GE Medical Systems (Waukesha, Wisconsin), that unit developing database systems for pacemakers, implantable defibrillators and arrhythmia management. O'Connell described both as important tools for "taking advantage of strategic opportunities to partner with our customers to fulfill their needs in [both] the clinical and business areas." Besides helping health care adapt to changing trends on the business side, on the clinical side he estimated that "in three to five years, no doctor will implant a device that is not supported by a robust information network." O'Connell identified two purposes for increased emphasis on information technologies that can be linked to the company's device technologies. The first, he said, is to create another revenue stream for Medtronic, the second to continue to drive its share in the overall cardiovascular sector.

CareLink is a system for Internet monitoring of pacemakers and implantable cardiac defibrillators, its features including warehousing and secure storage of that data and its movement to a web site for access by nurses and physicians. O'Connell characterized this data as "personalized information [that is] identical to that obtained in the physician's office." Since this information "can be used to replace an in-office interrogation," the system essentially offers a virtual office visit or can provide "a unique triage capability when a trip to the clinic is highly inconvenient," he said. And when an office visit is required, the system can provide "convenient downloads ahead of time" to doctors or nurses, he added.

Paceart's expertise is in database software systems that can be used "to interpret cardiac data from several sources" and enables the translation of patient records into follow-up reports, according to O'Connell. He said that its 900 installations – including at 60% of "top heart centers" – make it the No. 1 vendor of its type.

While the company originally said that the CareLink and Paceart systems would be linked, O'Connell said that, at least initially, the systems would not be integrated but rather would be developed on parallel paths, to avoid loss of product focus in the early development stages, and have separate payment models. O'Connell projected that the developing patient management options could produce up to $100 million for the company within the next five years. The CareLink and Paceart offerings originally will be used for linkage to a fairly narrow range of devices, but they could eventually be linked to a broader range of systems, such a those for treating congestive heart failure, something that Medtronic is working on "as we speak," O'Connell said.

ABN Amro's Kotler, in reviewing the company's patient management initiatives, noted a potential obstacle to broad use of the CareLink system – the willingness of insurance companies "to pay the physician for a 'remote consult.'" To deal with this, Kotler wrote, "Medtronic has begun a heavy lobbying effort both at the regional Medicare level, as well as the legislative level." But for the Paceart system, he noted a revenue stream already in place from sales, and he predicted generation of "a nominal $10 million per year" for the company.

CardioGenesis in 28% staff cutback

Transmyocardial revascularization (TMR) specialist CardioGenesis (Foothill Ranch, California) last month said that it will cut sales and corporate staff by 28%, those moves coming with the report of a projected fourth-quarter loss that could range to $3.3 million.

CardioGenesis has developed laser systems used in TMR and percutaneous TMR (PTMR), procedures that punch holes in the heart to reduce angina pain. The latter procedure has run into regulatory roadblocks, however, and the general technology has been slow in commercial uptake, its critics charging that its ability to relieve pain is a simple placebo effect.

The company said the reductions realign staff in a way "appropriate for current and expected mid-term levels of revenue." It will pare staff by 28%, a combination of a 40% reduction in sales representatives and 15% reduction in corporate staff members. With the sales staff reductions, the sales and marketing organization now consists of 18. The cuts are expected to produce annual payroll savings of $1.7 million, CardioGenesis said, adding that it is pursuing other cost-cutting measures.

The company said that preliminary financial results for the fourth quarter indicate that its operating losses will range between $2.9 million and $3.3 million, before any special charges, on revenue ranging from $2.4 million to $2.6 million. The report reflects a failure to meet "internal expectations," mainly as the result of "a drop in laser sales resulting from unfavorable economic conditions, which negatively impacted capital equipment budgets of its prospect hospitals during the quarter and lengthened decision cycles," CardioGenesis said. Final results will be released in mid-to-late February.

Expressing disappointment concerning the company's prospects was Larry Haimovitch, president of Haimovitch Medical Technology Consultants (San Francisco, California), who follows the sector for Cardiovascular Device Update. Haimovitch said he has been enthusiastic about the company and the TMR system and felt that the technology had been well verified by five-year data reported in the New England Journal of Medicine. But he had concluded that "there is a high degree of reticence on the part of cardiovascular surgeons, who are conservative and adopt cautiously. I think they're just not going to adopt TMR, period."

He expressed confidence in the effectiveness of the technology clinically, "but it's a hard sell." And he continues to hope for FDA clearance of the company's PTMR system, as more likely to be adopted by the interventional cardiologists, a group he called "much more adoptive – they pick up things and run faster with them." CardioGenesis failed to win approval for the PTMR procedure from the FDA's cardiovascular devices panel last July, but the company is reworking its application and is still hoping to win marketing clearance before the end of this year.

The other main player in the TMR sector, PLC Systems (Franklin, Massachusetts), also announced in mid-January some "streamlining" that it said would improve market penetration for the technology, turning over all sales and marketing activities for its CO₂ TMR system to Edwards Lifesciences (Irvine, California). As a result of an exercised option, PLC's U.S. sales representatives are now members of Edwards' sales team.