International report: Japan approves St. Jude's Victory family of pacemakers

A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its Victory family of pacemakers, along with reimbursement approval.

Victory pacemakers are designed to promote more natural heart function, allowing the patient's own heart rhythm to prevail when possible by reducing the device's ventricular pacing using "smart pacing" technology. Called VIP (Ventricular Intrinsic Preference), this technology actively monitors the heart on a beat-by-beat basis to provide pacing only when it is needed, which St. Jude said has been shown to be better for patients' overall heart health.

It said smart pacing "also is an important clinical consideration, because studies have shown that excessive right ventricular pacing may contribute to heart failure in some patients."

The Victory pacemakers, which are fully compatible with St. Jude Medical's Merlin Patient Care System – the only cardiac device programmer available in the Japanese language – report all patient data in one concise "summary" screen, which the company said helps physicians quickly and easily interpret diagnostic information so they can best program devices for individual patient needs.

St. Jude said the device stores information that is measured over time, "so most standard follow-up tests already have been completed when a patient walks into the clinic."

The test results are displayed with follow-up electrograms to verify the test findings, and the company said detailed trend reports give physicians insight into a patient's cardiac status.

"Victory pacemakers offer significant advantages for patients and clinicians in Japan, including smart pacing technology that allows patients' hearts to beat on their own when possible and a more streamlined process for implant and follow-up procedures," said Paul Bond, chairman of St. Jude Medical Japan. "[They] were designed to provide physicians with the information they need to make better-informed decisions for their patient care."

The Merlin Patient Care System is the company's universal programmer for its pacemakers, cardiac resynchronization therapy (CRT) devices and implantable cardioverter defibrillators (ICDs). St. Jude said the system "allows physicians to quickly and efficiently program the Victory pacemaker at the time of implant and, if needed, re-program it at patients' follow-up visits."

Victory pacemakers are engineered to accommodate a wide variety of the diagnostic and therapy needs of patients, including algorithms that are designed to allow physicians better manage patients with atrial fibrillation (AF). AF is the world's most common cardiac arrhythmia that results in a very fast, uncontrolled heart rhythm caused when the upper chambers of the heart (atria) quiver instead of beating.

1st India hospital orders Novalis Tx system

Tata Memorial Hospital (Mumbai, India), one of India's leading cancer hospitals, plans to expand its program of advanced whole-body radiosurgery with the acquisition of a Novalis Tx radiosurgery platform from Varian (Palo Alto, California) and BrainLAB (Feldkirchen, Germany).

The hospital is constructing a new facility to house the device and plans to begin treatments next March. Tat Memorial, which currently delivers radiotherapy using three Varian Clinac linear accelerators and four telecobalt devices, has been carrying out stereotactic radiotherapy on Clinac accelerators since 2000, mainly for brain tumor patients.

The acquisition of the new Novalis Tx platform, which was ordered this past March, will enable clinicians at Tata to expand this program by routinely delivering state-of-the-art stereotactic radiosurgery to combat both cranial and extra-cranial tumors.

"The new machine will enable us to offer the most modern and advanced radiotherapy and radiosurgery treatments to fight cancer," says Professor S.K. Shrivastava, head of Tata Memorial's Department of Radiation Oncology. "It means our patients will receive very advanced treatments and we can carry out both straightforward and complex cases on the same device, which improves access and efficiency."

Shrivastava added, "We decided to acquire the Novalis Tx because this equipment is a technological marvel and an excellent combination of two leading suppliers of stereotactic radiosurgery technology. We have a history of introducing advanced radiotherapy treatments such as 3-D-CRT and intensity-modulated radiotherapy and this move is another step in ensuring our patients receive highly accurate and effective treatments."

Varian and BrainLAB joined forces late last year to introduce the Novalis Tx, which offers radiosurgery for malignant and benign lesions throughout the body, arteriovascular malformations, and functional lesions. It features very-high-dose delivery rates, which means that treatments can be delivered very rapidly. The technology also offers dynamic ultra-fine beam shaping and frameless patient positioning for more rapid and comfortable treatments.

Malaysian distributor for CTT device

Competitive Technologies (CTT; Fairfield, Connecticut) said it has signed an agreement with Able Global Healthcare (AG Healthcare; Kuala Lumpur, Malaysia), granting it exclusive distribution rights in Malaysia for CTT's pain management medical device.

CTT has exclusive worldwide rights to the device, a non-invasive method for rapid treatment of high-intensity oncologic and neuropathic pain, including pain resistant to morphine and other drugs.

Developed in Italy by CTT's client, Professor Giuseppe Marineo, the device was brought to CTT through the efforts of Professor Giancarlo Elia Valori of the Italian business development group, Sviluppo Lazio SpA, and assistance from the Zangani Investor Community.

The device, which CTT said has "a biophysical rather than a biochemical approach," uses a multi-processor able to simultaneously treat multiple pain areas by applying surface electrodes to the skin.

CTT has exclusive worldwide rights to the therapy device. Its partner, Geomc Co. of South Korea, is producing the device commercially for worldwide distribution.

The device has been used on more than 2,300 patients in seven hospitals in Europe.