A Medical Device Daily
St. Jude Medical (SJM; St. Paul, Minnesota) reported European CE-mark approval and first use of its EnSite Velocity Cardiac Mapping System, which it said has been designed to help physicians "more efficiently diagnose and deliver therapy to treat abnormal heart rhythms."
SJM is featuring the EnSite Velocity System in its booth at this week's Heart Rhythm Society (Washington) scientific sessions in Boston.
The company said advancements in the EnSite Velocity System's design are focused on increasing procedural efficiency, from set-up and operation, to clinical application and use.
With new hardware and software, the system offers simple set-up and connections, an intuitive software interface and includes two key new capabilities: the OneMap tool and RealReview function.
The OneMap tool enables physicians to simultaneously create a detailed cardiac model and electrical map using multiple catheters and electrodes, allowing physicians to collect and display more relevant patient information in a shorter amount of time.
The RealReview function provides real-time, side-by-side views of the live procedure and previously recorded portions of the procedure, giving physicians a quick and easy comparison of events and results at different times throughout the procedure, without losing the ability to visualize and navigate catheters in real-time.
"The EnSite Velocity System allows me to efficiently collect anatomical and mapping data with whichever catheter I believe is most appropriate for the procedure. The system's versatility and catheter choice is important, providing me with enhanced control during the procedure," said Tony Chow, MD, of The Heart Hospital (London).
St. Jude said the system "maintains the strengths and clinical utility that have made the EnSite System the leading cardiac mapping system, while incorporating significant improvements into the design. Additionally, the EnSite Velocity System is an open platform, which means that it is compatible with essentially all diagnostic and ablation catheters, recording systems and energy sources used for ablation procedures.
"The EnSite Velocity System functions as though it were designed with the entire lab in mind; the simple setup and intuitive operation are incredibly helpful in supporting efficient procedural workflow," said Christopher Piorkowski, MD, of Herzzentrum Leipzig (Leipzig, Germany). "Because my practice has a fast-growing population of patients to serve, such efficiency gains benefit not only my patients but also other members of my team."
Jane Song, president of the St. Jude Medical Atrial Fibrillation Division, said, "As the next generation in cardiac navigation and visualization technology, the EnSite Velocity System is designed to integrate seamlessly with existing lab technology, while having built-in flexibility to allow for integration with future technologies."
St. Jude also reported CE-mark approval of its Promote Accel implantable cardiac resynchronization therapy defibrillator (CRT-D). The Promote Accel CRT-D automatically tailors treatment to individual patient needs by measuring the heart's reaction to therapy and ensuring that the heart is responding, providing the dual benefit of added safety for the patient and added efficiency for physicians.
Oxford Biosensors is for sale
UK biotech firm Oxford Biosensors (Oxford, UK) has been put up for sale following the withdrawal of its existing backers.
The company has developed technology for point-of-care electrochemical testing for lipids and other analytes, for use in the cholesterol, diabetes and renal function diagnostic testing markets.
Oxford's lead product is a lipid diagnostic panel designed for monitoring patients' cardiac risk and the impact of therapy, leading to an improvement in clinical outcomes. The panel enables the testing to be undertaken in the doctor's office in about five minutes with results comparable to those performed in a clinical laboratory. This product is now being finalized for FDA approval and launch.
In addition to the lipid panel, the company has begun work on other panel products for metabolic conditions, diabetes and renal function. Initial feasibility on these pipeline products has already been completed.
Since 2000, Oxford Biosensors has raised about 18 million, including equity, grants and corporate partnership revenues.
The company operates from a research and development facility at Yarnton, Oxford.
Portugal distribution deal
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, said it has entered into a definitive, five-year distribution agreement with Ekrior, a division of Avanco Sistemas Medicos (Barcarena, Portugal), expanding on and replacing a previous agreement with Avanco.
Ekrior will market the Sonablate 500 High Intensity Focused Ultrasound (HIFU) System as a mobile, fee for use service to hospitals throughout Portugal. Misonix and Ekrior will share the fee for use revenue for the length of the agreement plus any extension periods. Procedure minimums for fee per use revenue are part of the agreement.