A Cardiovascular Device Update

In a move spurred by the success of the Heart Choice pilot program, UK Health Secretary Alan Milburn has unveiled the next step in an effort to give more National Health Service (NHS) patients choice over where and when they have elective surgery procedures. As of the beginning of October, hundreds of patients in London who have been waiting more than six months for cataract surgery were given the opportunity to choose to have their treatment at a different hospital in order to cut the waiting time. By next spring, similar choices will be made available to patients waiting for orthopedic procedures; ear, nose and throat treatment; general surgery and other specialties.

Those steps follow a pilot program put into effect in July, when almost 2,000 cardiac patients across the UK who were waiting six months or more for an operation at their local hospital became eligible to choose to be treated elsewhere in the NHS or in the private sector. Nearly 400 patients had made such a choice under the Heart Choice program as of the end of last month.

"If we want a health service which puts patients first, then patients have got to have more power," Milburn said. "And that means they've got to have some choice." He said that, "subject to evaluation and assuming these [pilot projects] continue progressing successfully, Choice will be extended to other parts of the country." Milburn said that by the end of 2005, "every hospital appointment will be booked for the convenience of the patient, making it easier for patients and their [doctors] to choose the hospital and consultant that best suits their needs."

The Department of Health said that in order to help the NHS build on the success of the Heart Choice plan, an extra 10 million pounds "will be pumped into areas across the country with the highest levels of coronary heart disease." Being allocated on top of the extra 100 million pounds already invested this year toward improving heart surgery, the 10 million pounds is "to help ensure rapid progress in reducing waiting times and extending patient choice."

Ratcheting up its self-imposed pressure to improve the healthcare offerings of the NHS, the Department of Health also said that instead of a previous target date of 2008 for achieving a maximum three-month wait for a heart surgery procedure, the target date now has been recast to March 2005.

As part of the Heart Choice program, every heart surgery center in Britain has appointed at least one patient care advisor, with those advisors serving as single contact points for patients and their families before, during and after treatment. In addition to having the right to choose faster treatment at another hospital either in the NHS or the private sector, cardiac patients soon will be offered the option of treatment in other countries, the Department of Health said.

The Heart Choice initiative is accelerating progress made in reducing waiting times in general, with the Department of Health saying in a report issued two days after Milburn's announcement that the number of British residents waiting more than 12 months for inpatient treatment at NHS facilities dropped by 700 in August to 18,200. That represented a reduction of 26,700 or nearly 60% from year-earlier figures. Of the 18,200 waiting at least 12 months for treatment, 32 had waited more than 15 months, which represented a drop of 10,900 from the year-earlier figures.

Sell-off of Centerpulse cardio units continues

Centerpulse (Zurich, Switzerland) said last month that it is selling its Vascutek (Glasgow, Scotland) vascular-grafts business to Terumo (Tokyo) in a deal valued at $170 million. Vascutek, acquired in 1990 by Centerpulse's predecessor company, Sulzer Medica, manufactures vascular prosthetic grafts for treating diseased and damaged arteries. Its knitted and woven polyester grafts are produced in both sealed and unsealed versions.

Vascutek also is developing the Anaconda, a modular system designed for endovascular aneurysm repair. The company says its implants, consisting of nitinol combined with a woven prosthesis, can be delivered through smaller introducers than other available systems. The company, which has just under $24 million in annual revenues, employs about 240. Its U.S. plant is located in Austin, Texas. The sale is pending regulatory approval and is expected to close this month, according to Centerpulse.

The company said the sale is the second step in its plan to divest its cardiovascular interests, following the sale of its IntraTherapeutics (St. Paul, Minnesota) subsidiary to Microvena (Minneapolis, Minnesota) for $95 million. That sale is expected to close this month. Sulzer had acquired IntraTherapeutics, which employs about 95 people, for $145 million just last year. The company's products include balloon-expandable non-coil stents and self-expandable coil and non-coil stents for use in peripheral arteries.

The Swiss company said that firm bids are expected soon on its remaining cardiovascular businesses. Centerpulse announced in June its intention to divest its cardiac and vascular operations in order to put greater focus on its core orthopedic, spine, dental implant and biologics activities.

'Powerhouse for improvement'

The plan to merge the UK's Medical Devices Agency (MDA) and Medicines Control Agency into a single entity next year will be a "powerhouse for improvement" in the regulation of healthcare technologies and therapies, in the view of Health Minister Philip Hunt. Speaking at the device agency's annual conference in late September, Hunt said the formation of the Medicines and Healthcare Products Regulatory Agency (MHRA) will represent "a model of common sense and proportionate regulation."

He said the new agency would be "all about patient safety." Assuring such safety "is not an optional extra," Hunt said in his talk. "People going into hospital or being treated at home ... believe that everything is there to make them well again and that healthcare products and medicines are safe and effective."

The British government announced in mid-September that the MHRA would make its bow next April. At the time of that announcement, Hunt said that a key reason for merging the two existing agencies into one is what he termed "the increasing convergence in the fields of pharmaceuticals and medical devices." He said that as technology develops, "there are likely to be growing numbers of products that cross the borderline between medicines and devices."

Evotec, MediGene, in cardiology discovery

MediGene (Martinsreid, Germany) has secured the cooperation of Evotec (Hamburg, Germany) in launching a new company out of MediGene's recently spun off cardiological drug discovery program. The new company will be known as Genovation. The participants described their cooperation as a strategic partnership. Under the terms of the agreement, Evotec will hold up to 15% of Genovation. Evotec will contribute expertise in drug discovery and will conclude an exclusive service agreement to carry out chemical screening and substance optimization procedures. No additional financial terms were disclosed.

The cooperation with Evotec is just the first step toward launching the new company, and MediGene is actively seeking additional investors who will contribute fresh capital. Peter Heinrich, CEO of MediGene, told CDU's sister publication, BioWorld International, "We expect to complete financing by the end of the year." He added that MediGene's contribution to Genovation would be strictly assets and not additional cash. "We have been getting good feedback" on the spin-off, Heinrich said. He also said that MediGene was concentrating on its core competencies and was on its way to reaching its goal of becoming a fully integrated biopharmaceutical company. The goal will not be reached only with organic growth, he said, noting that MediGene also plans on making acquisitions.

Genovation's field of cardiology was the first area of investigation for MediGene's drug discovery program, started in 1995. Research into a once-promising compound for congestive heart failure was discontinued this summer after disappointing results in Phase II trials.

CE mark for Thermosense system

Thermocore Medical (Guildford, UK) has completed a patient safety and feasibility trial for its Thermosense coronary temperature assessment system, with the thermograpy catheter receiving CE mark approval. Stefan Verheye, MD, of Middleheim Hospital (Antwerp, Belgium), presented results of the Thermosense study during the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington.

Patrick Serruys, MD, of Thoraxcenter Rotterdam (Rotterdam, the Netherlands), presented further data on the Thermosense system during a vulnerable plaque symposium held at the TCT gathering. He said that current techniques such as angiography "can't distinguish between vulnerable and stable plaques, so we can't tell which patients are walking around with a potentially deadly time bomb inside them." But, Serruys said, "we do know that inflamed tissue is hotter than healthy tissue, so we think that one of the possible routes to identifying these vulnerable plaques is to measure the temperature in the coronary artery walls and look for abnormalities."

He said he envisions that the Thermosense system "could allow doctors to take the angiography procedure one step further by detecting these unstable plaques in their early stages and allowing the doctor to start the patient on an appropriate course of preventive or stabilizing treatment."

Smallest ICD released in Europe

Guidant (Indianapolis, Indiana) released in Europe its next-generation implantable defibrillator family, the Vitality implantable cardioverter defibrillator (ICD) system, which received the CE mark in July. The company touted the new devices' reduced size, longevity and new advanced rhythm management solutions. Guidant called Vitality the world's smallest ICD at 30 cc. The platform's rhythm management solutions feature algorithms intended to pinpoint the origin of fast or erratic heartbeats in order to allow a physician to quickly program the most appropriate therapy.

Bayer and Shield in homocystine test deal

Bayer Diagnostics (Tarrytown, New York) and Axis-Shield (Dundee, Scotland) have agreed to develop Shield's homocystine assays for use on the ADVIA Centaur and ACS:180 analyzer systems. Homocystinemia has been identified as a risk factor in coronary diseases.