CD&Ds

A panel of the UK's National Institute for Health and Clinical Excellence (NICE) in late July denied an appeal filed by Cordis (Miami Lakes, Florida), a unit of Johnson & Johnson (J&J, New Brunswick, New Jersey), regarding reimbursement for drug-eluting stents (DES) used to treat coronary artery disease.

NICE issued a guidance in February recommending DES use as a "possible treatment" for coronary artery disease patients - but only if two conditions are met:

• The artery to be treated is less than 3 mm in diameter or the affected section of the artery is longer than 15 mm conditions that indicate a patient is at high risk of requiring further interventions if a conventional bare-metal stent (BMS) is used.

• The additional cost of a DES over a BMS device is no more than $600.

Cordis appealed the guidance, saying it was too restrictive and arguing that NICE was seeking to fix or control the price of the stents or to establish procurement policy for the UK's National Health Service. It cited evidence that DES devices are cost-effective at price premiums up to $800 to $900 over the cost of BMS devices, saying this should be reflected in the guidance.

At about the same time, NICE re-released its final guidance, confirming the criteria it set forth in the February guidance.

"We're disappointed that NICE's appeal panel did not uphold our appeal, and we're in the process of evaluating our options regarding the appeal panel's ruling," said Christopher Allman, a J&J spokesman.

Andrew Dillon, CEO of NICE, in a statement said, "The guidance is the result of careful consideration of the evidence, as well as comments received during consultation and further economic modeling. The independent Appraisal Committee took into account the risks and benefits of the different types of stents, and the significant additional costs involved in the use of drug-eluting stents compared to bare-metal stents."

Dillon said that this decision, guiding the recommendation for use of DES, will ensure that, despite their higher cost, they still will continue to be an important treatment option for patients "who would be at high risk of requiring further interventions if a bare-metal stent was used instead."

According to NICE, J&J could challenge the decision by applying to the High Court for permission to apply for judicial review.

Japanese approval for St. Jude lead

St. Jude Medical (St. Paul, Minnesota) reported receiving both regulatory approval and reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its Durata defibrillation lead, which it calls a next-generation high-voltage lead.

The Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle (RV) shock coil intended to enhance ease of use and handling for physicians implanting an implantable cardioverter defibrillator system in patients at risk for dangerously fast heart rhythms. It also incorporates Optim insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads.

The company said that Optim insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.

The lead is the same size as the company's Riata ST Optim lead which it says is, at 7 Fr, the smallest-diameter high-voltage lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow, a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.

"The Durata lead represents St. Jude Medical's commitment to continuous innovation and improvement, incorporating new features based on physician feedback to better serve our physician customers and their patients," said Eric Fain, MD, president of St. Jude's Cardiac Rhythm Management Division. "This new lead combines next-generation technology with features designed to increase reliability and long-term durability and thereby reduce risks."

CE mark for CryoMaze products

ATS Medical (Minneapolis), a provider of cardiac surgery products and services, reported last month that it has received ISO certification for its quality systems to manufacture and CE-mark approval to distribute its CryoMaze cardiac ablation products in the European Union. These approvals, in combination with the completion of transfer of the U.S. 510k rights and validation of the manufacturing processes, enable the company to sell the ATS product line in both the U.S. and Europe.

ATS said the regulatory approvals are the final step in the integration of the surgical ablation business, which the company acquired in June 2007. Since the acquisition, ATS has purchased devices from the previous manufacturer to support worldwide sales. In anticipation of these approvals, the company began ramping up its manufacturing efforts in the second quarter and said it believes its current manufacturing capacity is sufficient to meet demand.

"We are elated by the achievements of our manufacturing and regulatory teams in obtaining these key certifications, enabling us to supply both U.S. and European markets with devices manufactured by ATS Medical," said President/CEO Michael Dale. "We are extremely pleased with the market's acceptance of our ATS CryoMaze products and believe this business will be a primary contributor to the acceleration of revenue growth over the next several years."

He added, "With the integration process behind us, we are now able to focus our efforts on manufacturing process improvements and cost reductions and have the flexibility to develop new products on a reduced timeline."

More than 150,000 ATS Open Pivot Heart Valves, which utilize a unique pivot design resulting in exceptional performance and low risk profile, have been implanted in patients worldwide.

The ATS 3f brand encompasses multiple tissue heart valve product offerings at varying steps from market introductions to clinical trials to development projects that incorporate less-invasive valve replacement technology.

ATS said its focus on the cardiac surgery segment is further strengthened by offerings that include ATS Simulus annuloplasty products for heart valve repair and ATS CryoMaze surgical ablation products.

Demand grows for monitoring equipment

Cardiovascular monitoring systems are increasingly in demand in Europe, according to global consulting firm Frost & Sullivan (F&S; London). The need for sophisticated, but user-friendly equipment at affordable rates will offer market participants considerable growth opportunities in this sector.

New analysis from F&S, European Diagnostic Cardiovascular Monitoring Equipment Markets, finds that the market totaled revenues of $350 million in 2007 and estimates this to reach $491.3 million in 2014.

"Lifestyle changes and an aging population underpin the increasing incidence of cardiovascular-related illnesses," says F&S research analyst Gideon Praveen Kumar. "These trends contribute to an increased need for diagnostic cardiovascular monitoring equipment market in Europe."

The report says cardiovascular diseases are one of the leading causes of premature death. In Europe alone, about $160 billion is being spent annually on the diagnosis, treatment and rehabilitation of patients with cardiovascular diseases. Furthermore, statistics have revealed that one in five teenagers suffers from the early signs of heart disease. Under such circumstances, says Frost & Sullivan, diagnostic cardiac monitoring systems are finding wider application in hospitals and cardiac rehabilitation centers to enable effective diagnosis and therapy.

The report notes that ECG is a well-established procedure, but there have not been significant technological breakthroughs in recent years and the market continues to persist with old technologies. This situation has been exacerbated by the lack of funds for the research and development of innovative technologies. In addition, the focus on treatment, rather than monitoring modalities, is threatening to impede market momentum. "Larger participants have always had the upper hand because of their reputation and the superior brand awareness that they have been able to create," notes Kumar. "This is threatening the survival of smaller competitors."

Despite intense competition, he says growth opportunities exist for companies that form strategic alliances to meet evolving end-user demands. Market expansion will be sustained by technological enhancements that promote greater user friendliness and improve networking and communication capabilities, while supporting cost efficiencies.

Angiotech receives CE mark

Angiotech Pharmaceuticals (Vancouver, British Columbia) last month reported receiving the CE mark for the HemoStream Chronic Dialysis Catheter, allowing it to begin marketing the device in Europe. The CE-mark approval follows by a year Angiotech's receipt of FDA approval for the catheter.

Angiotech entered into an agreement with Rex Medical (Conshohoken, Pennsylvania) in April 2007 granting it an exclusive license to market and distribute HemoStream worldwide. "With Rex Medical as our worldwide licensing partner, we look forward to expanding HemoStream's availability in Europe as well as in the U.S.," said Dr. William Hunter, president/CEO of Angiotech.

Dealing with the dialysis requirements of patients suffering from end-stage renal disease (ESRD) is a rapidly growing global healthcare challenge, Angiotech said. "Chronic dialysis catheters, such as HemoStream, are used as long-term vascular access for hemodialysis," it said. "HemoStream may also be used as a temporary access while more permanent options mature or become ready for use, such as surgically created AV fistulas."

Rex Medical is a private company specializing in developing minimally invasive medical devices targeting the cardiovascular, venous access, endosurgery and oncology markets.

Angiotech markets treatment solutions for diseases or complications associated with implants, surgical interventions and acute injury.

Arterial stent study begins in NZ

Flexible Stenting Solutions (Eatontown, New Jersey) said in August that a physician at Auckland City Hospital in New Zealand successfully implanted several of its third-generation arterial stents for the treatment of peripheral vascular lesions involving the superficial femoral and popliteal arteries. This first-in-man clinical trial using a full range of stent sizes, including 120 mm, was performed by Associate Professor Andrew Holden, MD, director of interventional radiology at Auckland City Hospital and the principal investigator in the trial.

"The flexible stent handled both stenoses and occlusions in the femoro-popliteal artery segment as well as I had hoped with excellent immediate appearances following deployment" Holden said. "Overall, I felt the stent and delivery system performed very well in the acute phase and I await the longer term follow up in these patients with great interest."

Patients with lesion lengths up to 100 mm and fully occluded lesions were included in the study.

RESPeRATE device available via e-Costco

InterCure (Lod, Israel) reported that its RESPeRATE hypertension treatment device, designed to lower blood pressure, is now be sold through the online arm of Costco Wholesale (Issaquah, Washington). "Costco aims to bring the best products available to our members at the lowest price," said Monica McArthur, buyer for Costco. "By offering RESPeRATE to our members, we are providing access to a proven therapy that fits in well with our current healthcare items and offerings."

"The availability of RESPeRATE on Costco.com signifies a new avenue of retail distribution for InterCure," said Scot Dube, InterCure VP of sales. "Providing consumers access to RESPeRATE through a wholesale club opens the door to a host of educated and loyal consumers looking for valuable options to manage their own health."

RESPeRATE is FDA-cleared for over-the-counter sale, and InterCure says it is the only medical device on the market clinically-proven to lower blood pressure through paced breathing therapy, the company said.

The breathing exercises with RESPeRATE relax the constricted muscles surrounding the small blood vessels, allowing blood to flow more freely and yielding a lasting reduction of blood pressure "within weeks."