A Medical Device Daily

Biotronik (Berlin), a pioneer in wireless remote monitoring technology for patients with cardiac devices, reported receipt of CE-mark approval of the newest generation of Biotronik Home Monitoring, which the company terms "the most advanced remote monitoring technology of its kind."

Using an intelligent "traffic light" system, Biotronik Home Monitoring quickly and easily identifies patients with the most clinically relevant events to streamline clinic workflow and improve patient care.

Biotronik was first to develop and introduce – somewhat more than seven years ago — an Internet-based remote monitoring system using the GSM telephone network and said it is the only cardiac device manufacturer to make this technology available across its entire product portfolio of pacemakers, implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices.

That allows physicians to remotely monitor their patients' clinical and device status from anywhere in the world. The company said Biotronik Home Monitoring is "the only system available on the market that enables remote device follow-up at any time."

It said Biotronik Home Monitoring "has integrated a traffic-light, severity-based display of patients' status to easily identify the most important information with just one click, allowing physicians to quickly review the clinical status of patients at a glance."

In excess of 130,000 Biotronik Home Monitoring systems have been implanted in patients in more than 50 countries worldwide, helping with patient management in some 2,700 clinics.

The IMPACT trial, which the company said is the largest home monitoring study worldwide with more than 2,700 patients enrolled, is investigating whether the risk of stroke can be reduced in ICD and CRT patients with asymptomatic atrial fibrillation by early detection of these arrhythmias utilizing Biotronik Home Monitoring technologies and a predefined anticoagulation plan.

The TRUST study examines the effectiveness of using Biotronik Home Monitoring to remotely monitor patients with the Lumax or Lumos ICDs compared to periodic in-office follow-up. TRUST also assesses using home monitoring and the Biotronik ICD device features to quickly detect atrial fibrillation and other arrhythmic events.

TRUST enrollment was completed early and study results are planned to be announced at the American Heart Association (Dallas) scientific sessions in November.

Danish hospital adding Elekta VMAT

Elekta (Stockholm, Sweden) said Odense University Hospital in Denmark has become the first Scandinavian cancer center to choose Elekta VMAT (Volumetric intensity Modulated Arc Therapy) to expand the capabilities of the hospital's radiation oncology department.

The company said the addition of this solution to the range of treatment techniques available at the center will provide physicians with the ability to treat cancer tumors with improved precision and accuracy, while at the same time significantly reduce treatment times.

Elekta VMAT has the ability to use single or multiple gantry arcs that sweep non-stop over the target isocenter, while simultaneously optimizing gantry speed, multi-leaf collimator leaves, dose rate and collimator angle.

The company said VMAT "delivers real-time flexibility in delivering uninterrupted prescriptions, dynamic leakage reduction and the flexibility to perform one or more multiple treatment arcs" and is the only clinically available VMAT solution able to do so.

"From the patient's perspective," Elekta said, "Elekta VMAT combines a significant reduction in treatment time with optimal avoidance of radiation dose to healthy tissues surrounding the tumor."

It added, "From the clinician's perspective, the reduction in treatment time makes it much easier to accurately target the tumor and the improved dose sparing offers new options to either increase dose to tumor or reduce side effects and therefore potentially improve outcomes. For the clinic administrator, reduced treatment times and the opportunity to increase dose and reduce the number of treatment sessions increases the number of patients that can be treated using their existing equipment."

"Elekta VMAT is unique in allowing us to optimize all parameters of treatment delivery in order to maximize dose to the tumor whilst minimizing unwanted radiation to healthy tissue" said Knud Aage Werenberg, head physicist at Odense University Hospital. "An added benefit of this new technology is that it dramatically reduces both treatment times and radiation dose, allowing us to treat more patients and minimize unwanted side effects."

ISO quality standard met by Pantec

Pantec Biosolutions (Ruggell, Liechtenstein), a privately-owned company developing technologies for transdermal drug delivery, said it has established a quality management system (QMS) in accordance with ISO 13485:2003 standards for medical devices.

In order to achieve ISO standards, Pantec Biosolutions implemented a QMS for its operations to ensure consistent quality of products under development. The company was audited by Swiss TS Technical Services and was awarded quality management certifications under MDD 93/42/EWG for the design, development, manufacturing and distribution of laser-based medical devices.

"By achieving ISO accreditation, Pantec Biosolutions can now offer full quality assurance in terms of product development and production of laser-based medical devices," said CEO Dr. Christof Boehler. "We are aiming to further develop our drug delivery platform by implementing only the highest standards of international quality and extending these standards to all aspects of our business."

Pantec is a specializing in using laser microporation technology to deliver large-molecular-weight drugs into the epidermis for local or systemic uptake. Its P.L.E.A.S.E. (Painless Laser Epidermal System) platform enables needle-free and painless administration of drugs through partnered patch technology.

The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of $1.5 billion to $2 billion.