A Medical Device Daily

The Cardiac Rhythm Management (CRM) business unit of Sorin Group (Mannheim, Germany) Cardiac Rhythm Management (CRM) business unit, this week reported increased focus on its innovative pacing mode, AAIsafeR, and on the utmost importance of preventing over-pacing of the heart's right ventricle at the 72th annual meeting of the German Society of Cardiology in Mannheim, which began Thursday and concludes tomorrow.

Sorin discussed its latest technology during a symposium on the opening day, saying that the symposium concurs with a European awareness campaign launched by Sorin to alert physicians on the risks associated with unnecessary ventricular pacing.

It said that several clinical studies have demonstrated that unnecessary right ventricular pacing from cardiac implantable devices significantly increases the risk of patients developing heart failure (HF) and atrial fibrillation (AF).

In response, Sorin has developed the AAIsafeR pacing mode designed to avoid unnecessary ventricular pacing by promoting the patient's natural electrical conduction (AV conduction). By regularly monitoring AV conduction, AAIsafeR pacing can automatically switch from physiological atrial-based (AAI) stimulation to right ventricular pacing (DDD) when necessary, i.e. only when normal AV conduction does not occur or occurs too slowly, causing blocks in the heart's natural electrical pathway (AV blocks).

AV blocks are classified into three categories according to the level of AV conduction impairment, with the first degree being the most benign and third degree the most severe form.

AAIsafeR is the only mode currently available that manages all types of heart blocks by delivering DDD only when needed. AAIsafeR also responds to conduction disorders occurring at night and to those occurring while exercising, thus allowing maximum comfort and safety for patients.

AAIsafeR pacing mode reduces unnecessary ventricular pacing to 0.1%, an unprecedented performance which significantly reduces risks of HF hospitalization, AF and mortality for patients while treating all heart blocks. It is estimated that 60% of pacemaker patients with dual-chamber indications could benefit from AAIsafeR.

“Because it favors intrinsic atrioventricular conduction in all situations, AAIsafeR pacing mode has the potential to become a gold-standard therapy for the vast majority of dual-chamber pacemaker and ICD patients,“ concluded Christof Kolb, MD, of the German Heart Center (Munich, Germany), a speaker at the Mannheim Congress.

Sorin Group's CRM business unit manufactures implantable pacemakers and ICDs, leads and Holter equipment and markets them worldwide.

Elekta showcasing Axesse at AANS

Elekta (Stockholm) said it will showcase a complete portfolio of stereotactic solutions at the upcoming annual meeting of the American Association of Neurological Surgeons (AANS; Rolling Meadows, Illinois), Saturday through Wednesday, at the Moscone Convention Center in San Francisco.

Elekta introduces the new Elekta Axesse, calling it the world's only 6-D robotic image-guided radiosurgery system optimized for treatment of the spine. The Axesse system uses exclusive stereotactic technology and 3-D imaging to ensure fast, efficient and accurate treatment for the patient.

In addition, Elekta will feature Leksell Gamma Knife, the only gold standard for treating indications of the brain and the world's only dedicated system for non-invasive radiosurgery. Patients are attracted by its gentle nature, short procedure time and documented clinical results. The patient often leaves the hospital the same day and returns to daily life, according to Elekta.

“Neurosurgeons possess rare, important skills and choosing the right stereotactic systems enables them to expand those skills,“ says Jim Rose, Elekta vice president of marketing for the Americas. “Elekta's stereotactic systems offer the unrivaled precision neurosurgeons need to treat cancer and other serious disease more aggressively than ever, without increasing risk to healthy tissue.“

EDAP unveils cost analysis

EDAP TMS (Lyon, France) released the data from a clinical cost analysis comparing the facility, training and human costs associated with treating localized prostate cancer by eight primary therapies. The results were unveiled during a scientific session at the recent conference of the European Association of Urology (Arnhem, the Netherlands) in Paris.

The analysis, conducted by Dr. Thuroff from Harlaching Hospital (Munich), concluded that Ablatherm-HIFU by EDAP offers clinical sites and hospitals significant potential for cost savings by reducing staff costs in treatment as well as offering increased facility efficiency.

The analysis demonstrated the average treatment time reported in the clinical literature for treatments shows Ablatherm-HIFU treatment time is similar to open surgery and shorter than robotic or laparoscopic surgery, radiation and brachytherapy allowing the clinic to treat more patients in a given period. More recent data from Ablatherm-HIFU sites suggests that times continue to decrease due to new technology introduced in the imaging system.

In addition to the time required to treat patients, the time required to learn a treatment procedure represents a significant investment cost by the medical staff. The analysis showed training regimen for Ablatherm-HIFU, which pairs new practitioners with highly experienced practitioners and applies already well-known basic urology skills, can be accomplished in as little as 10 treatments compared to typical procedural learning curves of 40 treatments for open surgery, up to 200 for laparoscopic surgery, 100 for robotic surgery, cryotherapy and brachytherapy and 40 for high-dose brachytherapy and external radiation.

The analysis did not address cost of treatment factors such as recurrence of the cancer requiring additional treatment, the cost of extended hospital stays required under some options, or the costs of treating side effects.

The analysis concluded that the total cost of care in treating localized prostate cancer included expenses often hidden or not considered in judging the value of treatments.

EDAP develops and markets Ablatherm, a High Intensity Focused Ultrasound (HIFU) treatment of localized prostate cancer. The company is also developing this technology for the treatment of certain other types of tumors.