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St. Jude Medical (St. Paul, Minnesota) last month reported CE mark approval of the Brio neurostimulator, which according to the company is the world's smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson's disease.

A 67-year-old man who has suffered from Parkinson's disease for more than 26 years became the first person to be implanted with the Brio neurostimulator.

Slightly larger than the typical man's watch, the Brio neurostimulator has a thin 10 mm profile and weighs 29 grams (about 1 oz). Additionally, the device has the greatest recommended implant depth of any rechargeable DBS device. The thin profile and greater implant depth potentially makes the neurostimulator less noticeable and more comfortable for patients.

"Deep brain stimulation therapy is often the preferred treatment for many Parkinson's disease patients," said Professor Volker Sturm, MD, chairman of neurosurgery at the University Hospital of Cologne (Cologne, Germany). "For these patients, device size and longevity are important considerations. The small size of the Brio neurostimulator is a real improvement and was a good choice for this patient."

Sturm's colleague, Mohammad Maarouf, MD, at the University Hospital of Cologne, performed the procedure.

The Brio DBS system delivers mild electrical pulses to specific targets in the brain, stimulating the structures that are involved in motor control. The system consists of a neurostimulator - a surgically implanted battery-operated device that generates the electrical pulses - and leads which carry the pulses to the brain to influence the irregular nerve signals responsible for the symptoms of Parkinson's disease.

"The Brio neurostimulator is an important addition to our family of deep brain stimulation systems," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "We are excited to offer physicians a best-in-class product to help them meet the needs of patients who require a smaller, long-lasting rechargeable system in order to better control the symptoms of this debilitating disease."

In addition to its small size, the company said the Brio has the longest battery life of any rechargeable DBS device currently on the market with a 10-year battery longevity approval. For patients this means the device should provide sustainable therapy and maintain a reasonable recharge interval for at least 10 years of use at high settings. The device's battery longevity may also maximize the time between device replacement procedures.

Parkinson's disease affects an estimated 6.3 million people worldwide, according to the European Parkinson's Disease Association. The disease usually develops in people between the ages of 40 and 70, with an average age of onset of 60 years.

St. Jude Medical is also currently developing new DBS applications to address a growing list of neurological and psychiatric disorders. Clinical studies are underway in the U.S. for depression and essential tremor.

MiCardia completes DYANA study enrollment

MiCardia (Irvine, California) reported the completion of enrollment in its European DYANA (Dynamic Annuloplasty Activation) study, designed to support submission for CE mark of the firm's Dynaplasty technology in Europe. Thirty patients were implanted with MiCardia's shape memory Dynaplasty mitral repair system, twenty-five in Germany at Homburg; Kiel; Leipzig and Stuttgart with five at William Beaumont Hospital (Royal Oaks, Michigan), the latter implanting a non-activation version of the device. Of the European implants, one quarter were successfully activated for correction of residual mitral regurgitation post-operatively. The company said it would submit six-month follow up data early in 2010 as part of its CE mark submission. First clinical indicators of device success are all positive. The enrolling hospitals and several new sites are set to continue implantation going forward, supporting the company's strategy to expand its base of clinical validation of Dynaplasty.

KCI expects Japanese approval for V.A.C.

Kinetic Concepts (KCI; San Antonio) said it has been informed by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan that in October the Ministry of Health, Labor and Welfare (MHLW) will grant regulatory approval for KCI to begin market development activities in Japan for its V.A.C. therapy product.

"This is exciting news for the medical community and patients in Japan," said Catherine Burzik, KCI president/CEO. "Our vision is to transform wound care in Japan by delivering advanced healing solutions and clinical know-how in a way that produces unparalleled outcomes."

Following regulatory approval this fall, KCI said it anticipates reimbursement approval in the first half of 2010. Once reimbursement approval is obtained, KCI will begin commercializing V.A.C. therapy in Japan.

Molecular Vision raises ≤ 2M in funding round

Molecular Vision (London), an emerging developer of quantitative point-of-care diagnostic devices, said last month that it had raised ≤ 2 million in a funding round that was led by the Imperial Innovations Group (IIG).

IIG has committed ≤ 1.5 million, with Acrongenomics, another existing shareholder, also participating in the round. This takes the amount of money raised by Molecular Vision to ≤ 3.2 million. IIG investment manager Maina Bhaman will join Molecular Vision's board.

Molecular Vision, which was spun out of Imperial College London, is developing a line of low-cost disposable devices for medical testing that will greatly extend the diagnostic tools available to the general practitioner. By enabling on-the-spot diagnosis, Molecular Vision's technology could reduce the need for patients to make repeat visits, accelerate treatment, free up clinician time and lower treatment costs.

According to the company, its technology has great potential in other markets including veterinary medicine, forensic science, environmental monitoring and military applications. The company said it has recently begun a major research collaboration with a global cosmetic company.

Edwards valve and catheter used in Germany

The University of Leipzig Heart Center (Leipzig, Germany) last month performed the first placement of a Sapien XT aortic heart valve from Edwards Lifesciences (Irvine, California) using the company's Ascendra 2 transapical delivery system.

"The Ascendra 2 system makes the transapical procedure easier and faster, which should result in broader surgeon and patient access to this approach," said Thomas Walther, MD, who performed procedure.

Europe has provided Edwards with a robust proving ground for its transcatheter heart valve system with products commercially available for both transfemoral and transapical valve delivery.

The majority of Edwards valves are delivery transapically via a small incision between the ribs and the new Ascendra 2 system improve on the existing system with a slimmer introducer catheter to minimize trauma and blood loss during the beating heart procedure.

Sapien XT, a new leaflet shape aortic valve with a cobalt chromium alloy balloon-expandable frame, is set for evaluation in the PREVAIL clinical toward the goal of CE-mark approval expected for 2010.

The Leipzig Heart Center patient is the first to be enrolled in that trial.

IBA selects Elekta software for site in Prague

Elekta (Stockholm, Sweden) will provide treatment planning and information management systems for a major proton therapy facility in Prague, Czech Republic.

Elekta is a provider of software solutions in the proton therapy market, as evidenced by its inclusion in an international proton therapy site, the Proton Therapy Center Czech in Prague.

The Center will be equipped with Mosaiq, an intuitive, yet powerful oncology information system that increases process efficiency, allows real-time access to clinical information and facilitates the highest quality patient care.

"The workflow-centric approach of Mosaiq will lead to increased patient comfort during the entire treatment process, as well as a high level of optimization of staffing activities on a daily basis", said Benoit Raskin, executive director of Particle Oncology Solutions Integration at Ion Beam Applications (IBA), whose mission is to fight cancer through solutions for cancer diagnosis and therapy.

The center will also be equipped with XiO, a comprehensive system that combines the latest tools and most robust dose calculation algorithms to generate quick, accurate treatment plans. Developed more than a decade ago, XiO for proton therapy is in clinical use at more proton facilities than any other commercial vendor with a similar product.

Raskin says XiO delivers a comprehensive planning functionality that addresses all of IBA's clinical needs. "It will support all proton treatment modalities: Scattered or Wobbled beams, Spot Scanning and Ocular treatment. XiO's powerful automated planning tools reduce planning time and increase clinical efficiency, in even the most demanding environments."

Mosaiq, as well as XiO treatment planning software from Elekta are designed to support different types of radiation systems and modalities, including intensity modulated radiation therapy (IMRT), and image guided radiation therapy (IGRT). This is in keeping with Elekta's long-standing history of supporting multiple vendors and open systems.

Elekta develops sophisticated state of the art tools and treatment planning systems for radiation therapy and radiosurgery, as well as workflow enhancing software systems across the spectrum of cancer care.

Rosetta inks deal with AXA in Italy

Rosetta Genomics (Philadelphia/Rehovot, Israel), a developer of microRNA-based molecular diagnostics, and AXA Diagnostics (Pomezia, Italy), a privately owned company that markets specialized diagnostic tests, reported the signing of an exclusive distribution agreement in Italy for Rosetta Genomics' three currently available diagnostic tests.

AXA will market Rosetta Genomics' miRview tests in Italy. Samples will be sent from Italy to Rosetta Genomics' CLIA-laboratory in Philadelphia for analysis. The terms of the deal were not disclosed.

"This latest distribution agreement with AXA Diagnostics marks Rosetta Genomics' entry into Europe, and we are excited to have AXA as our first partner in this region," said Ronen Tamir, COO at Rosetta. "We believe that there is significant need for our miRview tests in Italy, as well as worldwide, and that AXA is the right partner to bring these tests to cancer patients in Italy. As we have previously mentioned, we are continuously expanding our global distribution network, and believe that by the end of the year our tests will be available in other regions as well."

Integra reports 1st implant of DRT in Japan

Integra LifeSciences Holdings (Plainsboro, New Jersey) reported in September the first clinical implant of Integra Dermal Regeneration Template (DMT) in Japan. Hajime Matsumura, MD, of Tokyo Medical University Hospital, performed the operation. DMT obtained Seizo Hanbai Shonin approval from the Japanese Regulatory authorities in 2008 for the treatment of deep second- and third-degree burns (life-threatening burns). Century Medical distributes DMT in Japan.

DMT was the first regenerative product approved by the FDA for the treatment of life-threatening burns and scar revisions. Since gaining the initial FDA approval in 1996, it has been used on more than 100,000 patients, and is sold worldwide in over 40 countries, Integra said.

DMT is an advanced bilayer skin replacement system, designed to provide immediate wound closure and permanent regeneration of the dermis. The inner layer is placed in direct contact with the excised wound and consists of a complex 3-dimensional porous matrix that acts as a scaffold for cell migration and allows for regeneration of the dermal layer of the patient's skin. The outer layer is a thin silicone film that protects the regenerative matrix and the wound from infection and controls both heat and moisture loss. Once the dermis has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft, providing the patient with their own flexible, living skin.

Misonix restructures, expands sales organization

Misonix (Farmingdale, New York), a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, reported last month the restructuring and expansion of its sales organization in Europe. Two business units have been created; one for sales and service of the Sonablate 500 high intensity focused ultrasound (HIFU) system and the other for sales and service of the SonaStar ultrasonic surgical aspirator, the BoneScalpel ultrasonic bone cutting system and the SonicOne ultrasonic wound cleansing and debridement system.

The new Misonix HIFU Technologies business unit, which will be headed by Nick Stevens, will focus on a "fee for use" business model that will feature a combination of mobile services delivered directly to hospitals and "centers of excellence" to which qualified patients can be referred. The company's UKHIFU and Misonix France business units, which were created to support the "fee for service" business model, will be integrated into Misonix HIFU Technologies and will be overseen by the same management team.

Misonix EMEA (Europe, Middle East, Africa) will continue to sell and service the company's non-HIFU product platforms through a growing network of specialty distributors and will continue to be managed by Patrick Kyne. The company has more than 10 specialty distributors trained and operational with plans to rapidly expand the sales organization.

"We are confident that the separation of the European sales organization into two units will provide the market focus necessary to gain market share and grow revenues in key geographic locations," said Michael McManus, Jr., president/CEO of Misonix. "Both sales groups are staffed by seasoned, successful sales professionals dedicated to building customer awareness and brand equity for Misonix. We believe these sales teams will also provide us with the capability to effectively sell other Misonix labeled products to clinical customers in the years to come."

Chernew says single-payer not essential

The argument that a single-payer system is essential to cost containment has been around for a long time, and it resurfaced in the policy discussion last Wednesday sponsored by the policy journal Health Affairs (see accompanying story). However, one healthcare economist says that while the single-payer notion deserves some attention, it is not necessarily that last essential ingredient.

Harvard's (Cambridge, Massachusetts) Michael Chernew, PhD, told BB&T that he sees the single payer-as-monopsony argument as a "theoretically coherent argument, and I think it's an important one and one that is not made enough in this debate." He then stepped back by asserting, "I'm not arguing for an insurer monopoly," only that the topic deserves greater exploration.

"The market power of the providers is important" in the cost dynamic, Chernew stated. As to the question of whether fee schedules could achieve the same results as a monopsony, he cautioned that fee schedules "are extraordinarily hard to make work" regardless of scale. "At the state level it can be even harder than on the national level," he testified. Chernew pointed out that Blue Cross-Blue Shield entities in Massachusetts have an insurer quality contract that might serve as a model for fee schedules, but the Massachusetts experiment is still a bubbling beaker of uncertainty. Hence, while one cannot say insurers could never be successful in imposing a fee schedule on providers, "it's not obvious it will ever happen," Chernew said.

The frequently heard allegation about insurers is that having five or fewer offering coverage in a given geographic area is an unconscionable insurance oligopoly, but Chernew said that market concentration among payers is not necessarily the crux of the cost problem. "Some research suggests you could do competition with few providers," he said, but this is "not always a simple question of the number of providers." Some research suggests that three or four providers could generate a competitive field, he stated.

"If you try to fragment the insurance industry" with more competitors, Chernew said, policy makers could end up weakening the payers' market power against hospitals and other providers. "I think there's a general misconception about the role that insurers play versus the role providers play" in this competitive market.

Regarding whether health insurance exchanges (HIEs) with several tiers of plans will help clarify the true cost of coverage to enrollees, Chernew answered, "they're a step in the right direction. I can't tell you over time - and well see this works out in Massachusetts first - how this will play out," All the same, he said HIEs would force people "to confront the cost of care."

When asked whether the dilemma of the healthcare triad - cost, universal coverage, and full choice of physicians and therapies - was still in force, Chernew said, "I think that's a fair characterization. If you want cost containment, you're going to have to give up something on choice of plan or choice of therapy," assuming universal coverage is a fait accompli. Other nations "take away the autonomy of physicians to set fees," and in doing so, "it gives them the extra oomph to be able to get to the other goals they want to accomplish," he said.

"We have a hard time in the U.S." with the idea of stripping away physician autonomy, he noted, so the dilemma persists.

"If all Americans wanted the same trade-offs," it would be no problem, Chernew suggested. Many of the proposed answers are "much less rooted in science and much more in philosophy," a view he said leads him to conclude that "a lot of how this debate plays out is a little about the substance and a lot about a Rorschach test" about the roles of market and government.

- Mark McCarty

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