A novel mobile gamma camera unit — designed to bring widely used scintigraphic tomography (SPECT) out of advanced radiology suites and into the emergency room and intensive care units for seriously ill patients — has taken the first steps to advance beyond Sweden and enter new markets in Germany and India.
Adolesco (Stockholm, Sweden) reported partnerships in March with Aventyn (Carlsbad, California/Bangalore, India) and with Inter Medical Medizintechnik (Luebeck, Germany) that include enhancements to the current model as well as distribution agreements in new markets.
At the center of these deals is Cardiotom, a tomographic gamma camera that can be rolled into any hospital room, plugged into a wall socket and two minutes later can begin to acquire, reconstruct and display ectomographis images for the diagnosis of disturbances in perfusion of the myocardium. Adolesco built the self-contained Cardiotom system in collaboration with researchers from Karolinska Hospital, the Karolinska Institute and the Royal Institute of Technology (all Stockholm, Sweden).
Adolesco and Aventyn reported their agreement at the annual meeting of the Healthcare Information and Management Systems Society (Chicago) annual meeting in late February.
Key to the deal is Aventyn's presence in India, where the company said there is a high demand for mobile clinical imaging and where Aventyn plans to accelerate the adoption of Cardiotom. Aventyn also will be integrating its Clinical Information Processing Platform (CLIP) into the Cardiotom unit, a software system that aggregates, filters and routes data that is interoperable with clinical systems and patient health records.
Built on widely accpeted XML technology and supporting Health Language Seven standards, integration of CLIP is expected to create a competitive advantage for Cardiotom among national and regional health systems in Europe that are increasingly specifying compatibility with hospital information systems for new imaging equipment.
CLIP also features wireless sensor and RFID technology for asset tracking systems used at hospitals, a key selling point for an expensive and mobile imaging unit.
A specialist in software and hardware for nuclear medicine, Inter Medical agreed to promote Adolesco's product in the German market and that it would begin to manufacture the cameras for the Cardiotom this month.
Comparative studies conducted at the Stockholm hospitals of patients with suspected coronary artery disease in emergency and intensive-care settings demonstrated bedside tomographic scintigraphy is feasible, with ectomography and SPECT yielding similar diagnostic information and showing that it has been possible to use ectomography to define myocardial areas at risk and final infarct size.
A pilot study conducted at the hospitals demonstrated that brain scans also can be performed.
A cost/benefit analysis of the Cardiotom based on 79 patients showed startlingly favorable projections that an investment in the equipment would be recovered by a hospital in less than 18 months. Karolinska University Hospital and the County of Stockholm began a clinical investigation to verify these results that is expected to be completed later this year.
Biopure acknowledges more questions from UK for Biopure
Biopure (Cambridge, Massachusetts) reported receiving a comment letter from the UK's Commission on Human Medicines addressing the company's application for marketing authorization for Hemopure [hemoglobin glutamer — 250 (bovine)] pending with the Medicines and Healthcare products Regulatory Agency (MHRA). The company said the letter states that the commission was "reassured" concerning a number of the questions raised in its initial comment letter, but that other pharmacological and clinical issues either were not resolved by the submission from Biopure last November or were resolved only in part.
The comment letter posed several new questions and invited Biopure to discuss the issues with the MHRA team of medical, statistical and pharmaceutical reviewers.
The company said the commission has not advised it to withdraw the application. Biopure said it has been advised that such a request would be the customary means of indicating futility or rejection of an application.
"We intend to proceed by meeting and consulting with the UK regulatory review team, as suggested, as soon as possible, for clarification of their requirements," said Biopure Chairman/CEO Zafiris Zafirelis. "Based on preliminary advice, we are encouraged to proceed with the application."
German physicians implant 250 mm stent devices from NovoStent
NovoStent (Mountain View, California) reported that physicians in Germany have implanted 250 mm stents as part of the European clinical trial evaluating the use of the company's peripheral stent in the treatment of superficial femoral and popliteal artery disease.
The first case with the 250 mm stent was performed by Sven Braunlich, MD, and Dierk Scheinert, MD, in Leipzig. Scheinert, head of the department of angiology at the University of Leipzig Heart Center and Park Hospital, is the principal investigator in NovoStent's multi-center European study.
He said, "The stent is more flexible than any other that I have used, which is critical since stents used to treat real-world, long peripheral lesions have been shown to be more prone to fracture and restenosis."
Thomas Zeller, MD, director of the department of vascular medicine at the Heart Center (Bad Krozingen, Germany), also implanted the device and said, "I was impressed with the exact placement of such a long stent and the optimal clinical outcome for my patient."
NovoStent's self-expanding stent technology provides a range of vascular and non-vascular therapies, with the treatment of femoropopliteal disease being the first vascular application of the technology.
"The ability to deliver an extremely long stent is just one of the unique aspects of our technology platform and will help facilitate the evolution of patient care relative to the treatment of longer lesions," said G. Ray Martin, PhD, president/CEO of NovoStent. He added, "The 250 mm device is a natural extension of our clinical offering that has been used to treat more than 60 patients."
The company's stents feature a helical macrostructure, which NovoStent said maximizes flexibility, durability and radial strength, in addition to a micro-cell structure that can be customized for different vascular and non-vascular anatomies to achieve "optimal lumen coverage and prolapse control."
Biosensors in e-BioMatrix, 5,000-enrolled patient DES registry
Biosensors (Singapore) reported the enrollment of the first patient into its real-world registry for BioMatrix, the company's drug-eluting stent (DES) system that received CE-mark approval in January. The registry aims to collect long-term, five-year data on the safety/efficacy of BioMatrix in up to 5,000 patients.
The first patient, a 78-year-old woman suffering from incapacitating grade III angina, was treated with three BioMatrix stents by principal investigator Philip Urban, MD, chief of interventional cardiology, together with his colleague, Edoardo De Benedetti, MD, at H pital de la Tour (Geneva, Switzerland).
The company said the design of the e-BioMatrix online registry involves two parallel studies using the same protocol — a post-marketing surveillance study with 100% monitoring of 1,000 patients across more than 10 study sites and a post-marketing registry with 10% monitoring of 4,000 patients across 40 global sites.
Urban said, "I believe that this type of study is the right approach to confirm product performance in real-world clinical conditions, and I hope that the large number of targeted patients will confirm the safety profile of this exciting new technology."
The primary endpoint for both studies is MACE at 12 months, MACE here defined as a composite measure of cardiac death, myocardial infarction or justified target lesion revascularization.
The registry also will examine a range of secondary endpoints, including acute, sub-acute and late stent thrombosis over several periods; MACE at periods up to five years; and death and MI rates for up to five years.
"We are confident that the results from this comprehensive registry will confirm the long-term safety and efficacy of BioMatrix in real-world patients," said Jeffrey Jump, managing director of Biosensors Europe (Morges, Switzerland).
First procedures conducted with Powerlink system in Japan
Endologix (Irvine, California), maker of the Powerlink System for the minimally invasive treatment of abdominal aortic aneurysms (AAA), said the first two procedures with the company's Powerlink System have been performed in Japan after receiving Shonin approval. The procedures were performed at Osaka University Hospital in early Aporil by Toru Kuratani, MD, assistant professor of cardiovascular surgery.
The first case was a patient with an AAA, complicated by a narrowing of the left common iliac artery; the second case featured an anatomy that included a calcified stenosis of the aorta just above the aneurysm. Implantation of the device took one hour in the first case, 40 minutes in the second.
The clinical trainer for the first cases was Dr. Satoshi Kawaguchi, assistant professor of vascular surgery at Tokyo Medical University Hospital and a primary investigator of the Powerlink system in the Japanese clinical trial. "I believe the unibody design of the Powerlink simplifies the implant procedure by eliminating much of the guidewire manipulation required to implant multi-piece systems," Kawaguchi said. "I also believe the design will reduce the risk of late problems associated with stent graft migration."
Paul McCormick, president/CEO of Endologix, said, "In the U.S. the Powerlink was the fifth stent graft to obtain marketing approval, five years behind the first approved device. In Japan, the Powerlink System is one of only three approved commercial stent grafts and our approval came only 14 months following the first device approval."
Saying the company estimates that 14,000 open repair surgeries for AAA are performed annually in Japan, he added: "It is more of a level playing field as we launch in Japan and we believe that bodes well for product adoption. We believe that uptake in Japan will build as more physicians gain experience with our product."
Approval from the Japanese Ministry of Health, Labor and Welfare for the Powerlink System was received in early February, and reimbursement was announced by the Medical Insurance manager of the MHLW on March 31.
Encouraging data from Aastrom autologous stem cell trial
Aastrom Biosciences (Ann Arbor, Michigan) in mid-April reported what it termed as "encouraging" data from the first two compassionate use patients treated in Europe with the company's autologous stem cell therapy for dilated cardiomyopathy (DCM), severe chronic heart failure. Hans Michael Klein, MD, professor of cardiac Surgery at the Dusseldorf University Hospital (Dusseldorf, Germany), performed the first human application of Aastrom's Cardiac Repair Cell (CRC) product through direct injection into the heart muscle during open heart surgery in two patients late in 2007.
With the promising results from these first patients, Aastrom sasid that Klein's clinical activity is ongoing and additional patients are being evaluated for this treatment.
"I have had the opportunity to treat over 70 severe heart failure patients with cell therapy during my career. Until now, the most severe patients had little chance for long-term treatment success. CRCs have the potential to become the new standard of care for patients suffering from DCM,'' said Klein.
"These patients have a very low quality of life and fewer than 40% survive five years. The improvements we observe in their heart function allow us to measure their progress. We have noted this parallels the substantial improvement in the patient's symptoms and their heart failure stage.
Klein's first patient, a 74-year-old male with ischemic dilated cardiomyopathy who also suffered from extensive three-vessel coronary heart disease, renal insufficiency and unstable angina pectoris (chest pain), was treated with CRCs in November 2007. This patient met the clinical criteria of Class IV heart failure, with severe shortness of breath even without physical activity and when lying in bed.
Prior to treatment his left ventricular ejection fraction was 10%. After the CRC treatment and upon discharge from the hospital in January, his ejection fraction had improved to 25-30% and clinical improvement of his heart failure stage had been noted.
The second patient, a 69 year old female diagnosed with severe DCM, also suffered from extensive three-vessel coronary heart disease and had experienced multiple previous heart attacks. This patient had previously undergone coronary artery bypass grafting, several interventional treatments by catheter and had no other treatment options when she was admitted to the hospital.
Prior to treatment, her ejection fraction was 25%-30%; upon discharge from the hospital in February 2008 her ejection fraction was 45%.
"Our CRC product is distinguished from other cardiac cell therapies because it is an autologous, mixed cell product that contains large doses of stem and progenitor cells that may be ideal for patients with end-stage cardiac diseases,'' said Elmar Burchardt, MD, PhD, Aastrom VP of medical affairs.
Aastrom's proprietary CRCs received an Orphan Drug Designation from the FDA for use in the treatment of DCM in January 2007. The company says that it is on track for submission of a U.S. Investigational New Drug (IND) application for a cardiac regeneration clinical trial using CRCs this year.
The company has identified its target market for CRCs in the U.S. as the 1.8 million no-option heart failure patients, including patients suffering from DCM.
SynCardia reports training with its TAH-t heart by Vienna doctors
SynCardia (Tucson, Arizona) reported that Georg Wieselthaler, MD, clinical director of mechanical circulatory support, and his team from Vienna General Hospital at the University of Vienna, completed the first phase of certification training for its temporary Total Artificial Heart (TAH-t) in Tucson.
SynCardia said that Wieselthaler was the first surgeon to implant both the MicroMed DeBakey Left Ventricular Assist Device and the HeartWare HVAD. He also has implanted other ventricular-assist devices, including the Terumo DuraHeart LVAS.
Wieselthaler is secretary general of the International Society of Rotary Blood Pumpsp (North Rhine-Westphalia, Germany).
Vienna General is the 16th hospital in Europe and the 33rd hospital in the world to complete the first phase of CardioWest certification training. The third phase of that certification training is the proctored first implant of the artificial heart at that center.
Vienna General is the largest hospital in Austria, with 2,189 hospital beds. It treats nearly 95,000 in-hospital patients each year.
Currently there are 24 CardioWest certified centers worldwide, with nine additional hospitals undergoing the certification process, SynCardia said. Certified centers are located in the U.S., Germany, France, Canada and Austria, and hospitals in Sweden and Switzerland also have begun certification training.
SynCardia says that CardioWest TAH-t is the only FDA-, Health Canada- and CE mark-approved temporary total artificial heart in the world. Originally designed as a permanent replacement heart, it is approved as a bridge to transplant for patients dying from end-stage biventricular failure.
In the 10-year pivotal clinical study of the CardioWest heart, 79% of patients receiving the TAH-t survived to transplant.
PLC Systems in RenalGuard distribution agreement with Italian firm
PLC Systems (Franklin, Massachusetts), a company focused on cardiac and vascular device-based technologies, said it has entered into a three-year exclusive agreement with Artech (Cavezzo, Italy) for distribution of the RenalGuard System in that country.
RenalGuard is an automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. PLC said Artech does business with most of Italy's major interventional cardiology centers.
Artech will target early adopters who recognize the benefits of utilizing the unique fluid-balancing capabilities of RenalGuard System in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of contrast-induced nephropathy (CIN).
PLC Systems said CIN is "a major and growing problem," due to the increasing number of older patients, diabetics and patients with pre-existing renal failure — all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. It said CIN is the third-most-common cause of in-hospital acute renal failure.
Artech placed an initial stocking order for EUR 90,000 (about $144,000) for RenalGuard Consoles and single-use sets to support the initial sales launch of RenalGuard at selected major cardiology centers throughout Italy.
PLC President/CEO Mark Tauscher said that the Italian launch is supported by the clinical trial at the Centro Cardiologico Monzino-University (CCM-University; Milan). The study, led by Drs. Antonio Bartorelli and Giancarlo Marenzi, experts in the prevention of CIN, is expected to receive final approval by the ethics committee at CCM and lead to increased market visibility for our RenalGuard System."
PLC in late 2007 received the CE-mark for the RenalGuard System, concluded its pilot safety trial in the U.S. and received conditional approval from the FDA to begin a U.S. pivotal trial to study the effectiveness of RenalGuard therapy in the prevention of CIN.
Australian forces ink contract to buy Cardiac Science's PowerHeart AEDs
Cardiac Science (Bothell, Washington), a maker of advanced cardiac diagnosis, resuscitation, rehabilitation and informatics products, said it has won a five-year contract from the Australian Defence Force for the initial supply of 170 Powerheart G3 Pro automated external defibrillators (AEDs) and accessories.
The company said the Australian deal "adds to a string of international wins including a 300-unit delivery for public access defibrillators for train stations in the Netherlands and a 100-unit delivery to Eastern European military forces.
The company's G3 Pro AED provides what it said is the industry's first ECG color display, manual override features, multiple rescue capability and "the most advanced technology for rescue professionals' emergency treatment of sudden cardiac arrest."
All Powerheart AEDs feature the company's Rescue Ready technology to run daily, weekly and monthly self-tests of battery, internal electronics, software and pads.
Medtronic of Canada wins approval for Endeavor DES
Medtronic of Canada (Mississauga, Ontario) reported receiving regulatory approval from Health Canada's Therapeutic Products Directorate (TPD) for use of the Endeavor drug-eluting coronary stent (DES) system in the treatment of coronary artery disease. The company said sales of the Endeavor stent in Canada began last month.
Eric Cohen, MD, director of the cardiac catheterization laboratory at Sunnybrook Health Sciences Centre (Toronto), said that the device "has the advantage of being highly flexible, which permits delivery through tortuous vessels of the coronary vasculature. Having this stent available in Canada provides us with an important treatment option for Canadian patients."
Medtronic said it will provide annual updates on its Endeavor post-market clinical registries and trials for a period of five years as a condition of Health Canada's approval, including results under the proposed single-arm, post-approval study involving at least 5,000 patients that Medtronic will be conducting, as well as updates on studies and trials with respect to late stent thrombosis, myocardial infarction, death and optimal dual anti-platelet therapy.
About 90,000 stents are implanted in Canadian patients with coronary artery disease each year, according to research conducted by two Canadian cardiology societies.
Medtronic of Canada employs more than 400 and has regional offices in Vancouver and Montreal, as well as an education center and a museum in Mississauga.
•OrbusNeich (Hong Kong) reported receiving the CE mark for its Sapphire 1.25 mm PTCA dilatation catheter. Set for immediate rollout to the interventional cardiology community, Sapphire 1.25 mm is a small-diameter balloon catheter that OrbusNeich said is "designed specifically for the pre-dilatation of tight, calcified chronic total occlusion (CTO) lesions that require the best crossability."
The company said the product "provides physicians with enhanced pushability and superior kink resistance." It said the Sapphire 1.25 mm is the only balloon available in a 5 mm length, and 8 mm, 10 mm and 15 mm lengths also are offered.
OrbusNeich manufactures devices for the treatment of vascular diseases, including the Genous Bio-engineered R stent, an antibody-coated device that is the first stent to capture a patient's endothelial progenitor cells to accelerate the natural healing process following placement.
•St. Jude Medical (SJM; St. Paul, Minnesota) reported regulatory approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) for its Merlin Patient Care System, a universal programmer for cardiac resynchronization therapy (CRT) devices, implantable cardioverter defibrillators (ICDs) and pacemakers.
Merlin is designed to allow quick and efficient programming at the time of implant and at patients' follow-up visits. The system is a portable computer designed to help physicians efficiently conduct cardiac tests, analyze therapeutic and diagnostic data, and program implanted devices for optimal patient care.
St. Jude said physicians can quickly make changes to device therapy through the system's LCD touch-screen to decrease follow-up time.
Patients with ICDs, pacemakers or CRT devices require regular follow-up examinations to ensure that devices are programmed to provide appropriate therapy and to review a patient's response to programmed therapy. If a patient's condition has changed, clinicians can reprogram device parameters with the Merlin system to help protect the patient from abnormal heart rhythms.
•Abiomed (Danvers, Massachusetts) reported receiving the CE mark for its Portable Circulatory Support Driver. The Portable Driver supports Abiomed's AB5000 Ventricular Assist Device (VAD) for both in-hospital and out-of-hospital patients.
The Driver weighs 18 pounds and is "the lightest and most powerful biventricular system in the industry," according to the company, delivering pressures and vacuums equivalent to its AB5000 console and the recently approved iPulse combination console. It said that internal testing showed that the Portable Driver is capable of providing full support for a year's intended use.
The company said the Portable Driver was designed with the latest "smart battery" technology for extended power. "The quiet operation of the Portable Driver provides for minimal disruption of the patient's quality of life at home." Abiomed recently reported FDA labeling approval of one-year bench reliability for its AB5000 VAD, expected to complement the Portable Driver reliability.
The AB5000 VAD is CE-marked, and Abiomed said it has supported patients for up to 312 days. The Portable Driver is expected to enhance the company's bridge-to-transplant opportunity.
•Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, reported receiving CE-mark approval for its MitraClip system. The company says that the MitraClip is the first commercially available device which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).
Percutaneous mitral repair with the MitraClip device is performed by interventional cardiologists in the catheterization laboratory,and a heart-lung bypass machine is not required.
Saying that MR is the most common type of heart valve insufficiency in the U.S. and the second most common in Europe, Evalve added that the vast majority of patients are untreated. "[That] leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder and ultimately leading to heart failure," the company said.
In addition to CE-mark approval, Evalve reported completing enrollment in the high-risk registry arm of the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) in North America.
Evalve is the first portfolio company from The Foundry (Menlo Park), a medical incubator.
•Boston Scientific (Natick, Massachusetts) reported receiving approval from Health Canada's Therapeutic Products Directorate for sale of its Taxus Liberte paclitaxel-eluting coronary stent system. The company said it plans to launch the stent immediately in Canada.
"The Taxus Liberte Stent is a major advance in stent development and raises the bar for drug-eluting stent systems," said Serge Doucet, MD, cath lab director at the Montreal Heart Institute. "It offers enhanced ability to conform to the vessel wall and deliver across some of the most challenging lesions. This [approval] is welcome news for interventional cardiologists and patients in Canada who suffer from coronary artery disease."
David McFaul, senior VP, international, for Boston Scientific, said, "This stent is designed specifically for improved drug elution and deliverability. Coupled with our proven paclitaxel-eluting technology, Liberte provides physicians with next-generation performance."
•Onset Medical (Irvine, California) has received the CE mark for its SoloPath trans-septal access catheter.. SoloPath features Onset's Controlled Deployment Technology (CDT), to allow percutaneous access to the chambers of the left heart and surrounding vasculature.
Onset says it has developed several platforms based on CDT, representing what terms "a new and different approach to procedures requiring minimally invasive access to remote sites within the body."
CDT, it says, "allows introduction of a dimensionally small catheter to a specific site, which once positioned, can be radially expanded to deploy a semi-rigid sheath to maintain access to the treatment site."
The catheter enters the body at a diameter roughly 50% of the size of conventional access devices. "Once placed in the body, the device is expanded in a slow and gentle manner, using radial force to create an internal diameter larger than conventional devices," the company said."
SoloPath, the first cardiovascular application of CDT, allows interventional cardiologists and electrophysiologists a percutaneous approach to access the left atrium and pulmonary veins through the atrial septum for the diagnosis and treatment of conditions such as atrial fibrillation.