Royal Philips Electronics (Amsterdam, the Netherlands) and bioMérieux (Marcy l'Etoile) last month reported achieving an important milestone in the development of fully-automated handheld rapid diagnostic test solutions for use in hospitals at the point-of-care. This milestone comprises the integration of bioMérieux's assay technology and Philips' Magnotech rapid diagnostic testing technology into a disposable cartridge and handheld reader combination that achieves the speed, sensitivity and precision required for point-of-care testing. In time-critical situations, such as those encountered in emergency departments, coronary units and intensive care units, rapid diagnostic testing close to patients has the potential to improve patient outcomes and clinical workflows.
This achievement has been realized within a year of the two companies signing a joint development agreement in January 2010 to develop handheld diagnostic solutions, and means that both companies will now push forward with the development program. Philips will now further develop its prototype handheld reader into a fully-engineered rugged unit, while bioMérieux will continue the assay development. In addition, Philips will set up manufacturing facilities to be ready to produce the disposable cartridges for the 2013 commercial launch of the new solution.
Among others, one important target application for the Philips/bioMérieux technology is the measurement of cardiac Troponin-I levels in blood to assist in the rapid diagnosis of myocardial infarction. Troponin-I is typically found at elevated levels in patients who have suffered a heart attack. However, it is only present in the patient's blood in picomolar concentrations. In the past, detecting these extremely low concentrations has required costly time-consuming laboratory-based testing. Philips' and bioMérieux's success represents one of the first point-of-care multi-assay solutions with the potential to achieve lab quality performance.
Activaero raises €5 million
Activaero (Gemünden, Germany), a developer of controlled breathing inhalation devices, said it has closed a financing round of €5 million ($6.8 million).
LSP Life Sciences Partners (Amsterdam, the Netherlands), committed €3.5 million and were joined by the existing investors BioMedPartners (advising BioMedInvest LP II), VI Partners, Abalis Finance, Vesalius Biocapital I SICAR S.A., MedVenture Partners and existing shareholders who contributed another €1.5 million. MedVenture Partners advised the transaction. Jörg Neermann, a partner at LSP, will represent LSP in Activaero's supervisory board.
The company plans to use the proceeds to further develop its pulmonary drug delivery technology and to establish additional clinical activities.
Under the trademark of Akita, Activaero is developing inhalation systems which enable the use of Favorite in the therapy of pulmonary diseases and the development of new inhalant drugs.
Endosense completes enrollment in EFICAS I
Endosense (Geneva) reported enrollment completion in the EFFICAS I clinical study. EFFICAS is a study series intended to demonstrate that, in patients with paroxysmal atrial fibrillation (AF), the use of contact force control during cardiac ablation using the company's TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed with a standard catheter.
EFFICAS I is a 45-patient, single-arm, prospective, multi-center European clinical trial designed to demonstrate the correlation between contact forces applied during pulmonary vein isolation (PVI) and AF treatment efficacy at three months. The endpoint for the study is the occurrence of reconduction areas in the PVI lines, relative to the contact forces applied during lesion formation. While investigators perform the procedure with the TactiCath, they are blinded to contact force measurements; however, the contact forces applied are recorded. Patients are re-assessed with a mapping catheter at three months to identify potential gaps in the PVI lines. Contact force parameters from initial procedures are then analyzed to determine the relationship with lesion formation.
“We believe that the data from EFFICAS I will greatly advance the scientific understanding of contact force and the role it plays in the catheter ablation treatment of AF, as the data will allow us to better identify those force parameters that will deliver optimal patient outcomes,“ said Eric Le Royer, president/CEO of Endosense. “This study is yet one more proof point illustrating Endosense's leadership and commitment to clinical research of contact force in catheter ablation.“
The next study in the EFFICAS series is EFFICAS II, in which investigators will take full advantage of the real-time, objective TactiCath contact force control features to improve their ablation technique during lesion creation. Endpoints for EFFICAS II will include reduction in PVI gaps as compared to EFFICAS I. Outcomes data from EFFICAS I and II will help in the design of future, larger EFFICAS randomized studies with clinical endpoints. EFFICAS II enrollment is currently underway, Endosense said.
The TactiCath force-sensing ablation catheter and the TactiSys system are indicated for the treatment of AF and supraventricular tachycardia. Biotronik (Berlin) is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the U.S.
iCAD launches SecondLook Premier CAD
iCAD (Nashua, New Hampshire), a provider of advanced image analysis and workflow solutions for the early identification of cancer, announces the availability of its SecondLook Premier computer-aided detection (CAD) technology for digital mammography outside the U.S. SecondLook Premier was developed to provide breast imagers with the most advanced and customizable digital mammography CAD system providing improved cancer detection through increased sensitivity, reduced false positives and robust clinical decision support tools, iCAD said. The technology expands on the SecondLook platform and provides the richest set of clinical decision support tools available in the digital mammography marketplace today. Its CAD metrics provide automated measurements of mammographic characteristics while CAD iNSIGHT provides the rationale for each CAD detection. These tools provide industry leading CAD tissue and lesion characteristics to support the breast imager.
SecondLook Premier is optimized for leading digital mammography systems, GE Healthcare, and Siemens Medical Systems. It offers improved detection of soft tissue densities and calcifications, increased lesion marking in two views, and up to a 50% reduction in false negatives, according to the company. The algorithm also offers improved false positive performance, with reduced marking of vascular and other benign calcifications. It allows for three operating points to match breast imagers' reading preferences. These operating points span a wider range of readers' preferences and can be independently set for soft tissue densities and calcifications. In addition, iCAD's SecondLook Digital provides the most powerful flexible DICOM connectivity solution enabling universal compatibility with leading PACS and Review Workstations.
TomoTherapy installs first TomoHD in Germany
TomoTherapy (Madison, Wisconsin), maker of radiation therapy solutions for the treatment of cancer and other diseases, said that University Clinic Heidelberg, a radiation oncology institute, is expanding its cancer treatment capabilities with the introduction of the TomoHD radiation therapy system. This is the first TomoHD system to be installed in Germany.
In March 2006, University Clinic Heidelberg became the first facility in Germany to offer helical image-guided, intensity-modulated radiation therapy (IG-IMRT) using TomoTherapy's Hi-Art treatment system. The addition of the TomoHD radiation therapy system almost five years later will provide clinicians more flexibility to treat a broader patient population.
By combining TomoHelical and TomoDirect delivery modes, the TomoHD treatment system is a multi-purpose treatment system designed to target a broad range of cases requiring radiation therapy. The system's TomoHelical technique allows for continuous 360-degree delivery of radiation for complex treatment volumes, while the TomoDirect modality enables clinicians to choose multiple discrete angles for highly efficient treatment of more common targets. In either delivery mode, clinicians will use the same integrated processes they have become accustomed to with the TomoTherapy platform for planning, imaging and treating patients.
InspireMD's MGuard available in South Africa
InspireMD (Tel Aviv, Israel), developer of the MGuard net protective stent system, and Tau Medical (Johannesburg) InspireMD's exclusive South African distributor, reported last month that MGuard is now available in South Africa.
Graham Cassel, MD, performed the first deployment of the MGuard, mesh-based coronary stent system at Netcare Milpark Hospital. Cassel is president of the South African Society of Cardiovascular Intervention (SASCI; Tygerberg). The patient had suffered a heart attack and the PCI procedure was completed with optimal results and absence of any complications, according to the company.
“I had high hopes for this innovative system and my initial experience with MGuard was superb,“ Cassel said. “The device is easy to maneuver and I was done with the procedure in less than 10 minutes. This method could become a major breakthrough in the standard care of STEMI (heart attack) patients.“
Cassel will lead the South African arm of the MGuard MASTER randomized trial (MGUARD for Acute ST Elevation Reperfusion), a multinational randomized controlled trial designed to demonstrate the MGuard stent's superiority over standard care for STEMI (heart attack) patients.
The MASTER randomized trial will enroll 432 patients. The study's primary endpoint is complete ST segment resolution post procedure. Clinical follow-up will continue for one year and other important secondary endpoints will be measured. The trial will be conducted in 10 countries in Europe, South America and South Africa.
According to InspireMD, MGuard presents a novel combination of a coronary stent merged with an embolic protection specifically designed for acute MI patients. The embolic protection is comprised of an ultra-thin polymer mesh sleeve that wraps the stent. The MGuard coronary stent provides permanent embolic protection, without affecting deliverability. MGuard is CE mark approved.
Imaging Diagnostic installs CTLM in Indonesia
Imaging Diagnostic Systems (Fort Lauderdale, Florida) said last month it has completed installation and training for its CTLM in Jakarta, Indonesia at the Hang Lekiu Medical Center.
Hang Lekiu Medical Center provides multi-disciplined medical care in a patient friendly environment. This progressive medical center offers a variety of services through a network of specialists.
The CTLM system has received international certifications and licenses from the European CE mark, CMDCAS Canadian Health screening, China SFDA, India, UL, and ISO 13485.
The CTLM system is a breast imaging system that utilizes laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and visualizes the process of angiogenesis; which is a strong indication of tumor growth.
Mazor inks agreements for SpineAssist
Mazor Robotics (Caesarea, Israel), a developer of surgical robots and complementing products, reported in February that it has signed agreements in the Netherlands and Italy for distribution of its flagship product, SpineAssist, a surgical robotic system that enables surgeons to conduct spine surgeries in a safe and accurate manner.
The agreement in Italy was signed with AB Medica (Milan), a distributor of medical robotic equipment in Europe. AB Medica has introduced a significant number of innovative technologies to the Italian healthcare industry, including robotic surgical systems. In the Netherlands, Mazor signed a distributorship with InSpine and they have already completed a system sale to the Bergman Clinic in Amsterdam.
SpineAssist allows surgeons to place implants into a patient during spine surgeries, enabling them to perform minimally invasive spine surgeries with greater accuracy and less radiation, according to the company. It also is used in spinal deformity corrective surgeries such as scoliosis operations, which are considered the most challenging spine procedures. The system consists of a robot that is mounted on the spine during surgery and a workstation that runs advanced surgical planning software.
Perceval S aortic heart valve available in Europe
The Sorin Group (Milan, Italy), a developer of treatments for cardiovascular diseases, reported last month the commercial availability in Europe of the self-anchoring Perceval S aortic heart valve.
The Perceval S Sutureless biological valve is indicated for the rapid and minimally invasive surgical replacement of the aortic valve in patients suffering from aortic stenosis. Aortic stenosis is the most common acquired valvular heart disease in the western world and its occurrence increases with age. The prevalence of severe symptomatic aortic stenosis is typically reported around 3% in patients 75 years of age (this percentage also rises steeply with increasing age). The prognosis is poor for patients with severe symptomatic aortic stenosis and if after the onset of symptoms the patient remains untreated, the average survival is short – often only two to three years.
Perceval S is a surgical aortic valve with a unique self-anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place, therefore representing an evolution beyond traditional bioprostheses. The valve's functional component is made of bovine pericardium and is mounted on a super-elastic alloy frame. This system builds on a clinically proven stentless aortic pericardial valve implanted in more than 10,000 patients with proven durability and optimal hemodynamics. Clinical results in the first 180 patients implanted with Perceval S show a significant reduction in surgical procedural time for both isolated and complex aortic valve replacement with aortic cross-clamp times typically reduced by at least 50%. The hemodynamic performance was outstanding with low pressure gradients and large effective orifice areas at one and two years follow-up.
Capella initiates Italian clinical study
Cappella Medical Devices (Galway, Ireland) reported the initiation of the multi-center Italian Sideguard open label clinical study. This study represents Cappella's ongoing commitment to documenting the clinical benefits of Sideguard for side branch preservation as primary intervention for managing bifurcation related disease. Similar open label studies are also underway in the UK, Germany and South America, the company noted.
Cappella has also recently concluded an IVUS/OCT study designed to further demonstrate the mechanistic benefits of ostial protection and positive remodeling to minimize side branch luminal narrowing.