A Medical Device Daily

Earlier this month a 48-year-old male patient suffering New York Heart Association Class IV heart failure became the first recipient of the HeartWare ventricular assist device (HVAD) from HeartWare (Australia).

The implant was conducted at the Vienna General Hospital (Austria), and the surgical team was led by Georg Wieselthaler, MD, clinical director of Mechanical Circulatory Support at the University of Vienna . The implant marked the start of HeartWare's clinical study to support CE-marking.

The trial goal is to enroll 20 patients suffering advanced heart failure. The implants are to be conducted at the Vienna General Hospital, the Royal Perth Hospital (Australia), the Hannover Medical Centre (Germany) and Harefield Hospital (UK).

HeartWare said it expects to complete enrolment by the end of 2006. Wieselthaler said: “Our first clinical experience of the HVAD was extremely positive. The procedure was completed quickly and without incident, and our patient's early post-operative recovery has been excellent.“

The device features a small size and configuration that facilitated fast implant, and the procedure took just 85 minutes, “significantly less than the time typically required to implant other devices,“ according to HeartWare. “The patient was moved from the operating theater into the post-operative recovery area, conscious and off ventilation within seven hours. He continues to recover quickly and has met with his family. We are very pleased with these results.“

Stuart McConchie, CEO of HeartWare, said “The performance of the HVAD continues to support our high expectations for its clinical potential. The early success of this first implant marks the culmination of many years of effort in conceiving, designing, developing and testing what we believe to be the world's leading mechanical circulatory assist device.

HeartWare describes the HVAD as the smallest third-generation circulatory assist device available. It is a “full-output pump implantable in the pericardial space and the only centrifugal pump implantable above the diaphragm. The pump's impeller design, together with its integrated inflow cannula, help to ensure optimal blood flow characteristics which should, over time, allow reduction of the anticoagulant levels typically required for LVAD recipients.“

Biophan inks R&D pact with Siemens

Biophan Technologies (Rochester, New York) reported that it is pursuing a research collaboration between the European MRI division of Siemens Medical Solutions (Erlangen, Germany/Malvern, Pennsylvania) and Biophan-Europe (Castrop-Rauxel, Germany), to provide new solutions in the field of interventional MRI medicine and MRI-assisted minimally invasive surgeries.

The “anticipated“ collaboration, Biophan said, follows discussions between senior officers of the companies to further develop and commercialize potentially complementary MRI technologies.

Biophan-Europe, the company said, “is emerging as a major force of innovative solutions to enable effective MRI visualization of implanted medical devices, including heart valves, coronary and peripheral stents and vena cava filters.“

Siemens' MRI Division, in turn, has developed an MRI scanning technology with aperture configurations that could be complementary to Biophan's R&D program in this area, according to Dr. Michael Friebe, CEO of Biophan-Europe.

“Siemens' new 1.5 Tesla Open Bore MR Magnetom Espree with Tim technology, with its wide aperture, will be ideally suited for MRI-related interventional procedures, combined with our own expertise under Chief Technology Officer Dr. Andreas Melzer in positioning and interventional support hardware form a solid foundation for partnership and further joint development of medically needed MRI scanning solutions,“ Friebe said.

Biophan develops technologies to enable MR imaging to visualize the interiors of stents and other implants, and to enable the MRI-guided implantation of devices. Its founding goal was to make all biomedical devices capable of safely and successfully working with MRI problems.

Agendia in distribution pact with Opaldia

Agendia (Amsterdam, the Netherlands) and UK-based Opaldia said they have reached an agreement for distribution of Agendia's MammaPrint and CupPrint tests in the UK.

MammaPrint uses a 70-gene profile to classify breast cancer patients as “low“ or “high“ risk of developing distant metastasis in a 10-year period, thereby offering additional information to oncologists and patients concerning the subsequent treatment plan.

The CupPrint test is intended for cancer of unknown primary patients. For these cases finding the primary tumor and therefore providing most appropriate treatment is difficult by conventional techniques; the test identifies the primary tumor reliably which helps the oncologist find the best treatment with the objective of increasing life expectancy and reducing chemotherapy's side effects.

Opaldia bills itself as the first UK company to provide a fully comprehensive genetic medicine service, including molecular diagnostic testing and screening and information services for inherited disorders including cancers.

Agendia focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling.

Data points to new breast cancer tests

ExonHit Therapeutics (Marcy l'Etoile), a drug and diagnostic discovery company, and bioM rieux (Paris), a developer of in vitro diagnostics, reported reaching an important research milestone in the diagnosis of breast cancer.

They said that data to be presented on April 4 at the 97th annual meeting of the American Association for Cancer Research (Philadelphia) in Washington, is expected to lead to the development of novel diagnostic tests that will enable the early detection of breast cancer from blood. The data shows that the panel of genetic signatures identified by ExonHit can distinguish healthy women from those with early stage breast cancer. A total of 54 genes were able to correctly classify, with accuracy of 86.7%, a group of 92 women, 55 with Stage I/II breast cancer and 37 healthy women.

The companies said that a prospective multicenter clinical study in 1,000 women has been initiated to validate the specificity and selectivity of the markers identified.

“These results provide a clear proof of concept that by using a well characterised set of molecular markers in blood it can be possible to develop a valuable diagnostic test for breast cancer. This is an extremely positive development, which I view as a first success in our collaboration with bioM rieux,“ ExonHit said in a statement.

ExonHit has applied its gene profiling technology DATAS (Differential Analysis of Transcripts with Alternative Splicing) to the blood samples of healthy women and Stage I/II breast cancer patients. This has led to the identification and isolation of a set of genes including spliced variants that were differentially expressed between diseased and healthy women.

Significant diagnostic markers were then identified using ExonHit's SpliceArray technology applied to Affymetrix GeneChip microarray platform. As a result, a 54-gene signature was capable of correctly classifying 86.5% of the controls (32/37) and 92.7% of the breast cancers (51/55).