International Approvals: BSD-2000, Symphony AAISafeR 2, VNS Therapy Models 102/102R

Yael Waknine

April 12, 2005

April 12, 2005 — The State Food and Drug Administration of the People's Republic of China has approved a deep hyperthermia system for use in combination with radiation therapy and/or chemotherapy for the treatment of large, deep tumors; the European Commission has approved for use in the European Union a second-generation dual-chamber pacemaker that minimizes unnecessary ventricular pacing; the Republic of Korea's Food and Drug Administration and the Brazilian Ministry of Health have approved two implantable vagal nerve stimulators for the treatment of pharmacoresistant epilepsy.

Deep Hyperthermia System (BSD-2000) for Cancer Therapy in China

On March 14, the State Food and Drug Administration (SFDA) of the People's Republic of China approved a deep hyperthermia system (BSD-2000, made by BSD Medical Corp) for use in combination with radiation therapy and/or chemotherapy for the treatment of large, deep tumors in the breast, lung, colon, rectum, liver, cervix, bladder, stomach, and prostate.

The system superheats the tumor from the inside out with targeted radiofrequency waves produced by a series of patented annular phased array antennae, causing the cancer cells to become depleted and die. The cells also become less resistant to radiation and chemotherapy, thereby boosting the efficacy of both and increasing long-term survival.

The device was granted an investigational device exemption (IDE) by the U.S. FDA in December 2004, and premarketing approval is currently being sought. It has been approved for use in the European Union since 2000.

Second-Generation Pacing System (Symphony AAIsafeR 2) for Bradycardia in the EU

On March 22, the European Commission approved for use in the European Union (EU) a second-generation dual-chamber pacemaker (Symphony AAIsafeR 2, made by ELA Medical, a Sorin Group cardiac rhythm management company) that is capable of minimizing unnecessary ventricular pacing.

The device is indicated for the treatment of bradycardia due to sinus node dysfunction, transient atrioventricular (AV) blocks, permanent first-degree blocks, or paroxysmal atrial fibrillation. It is also indicated for managing AV conduction disorders that may occur with exercise or at night.

The device offers an advanced pacing mode that allows automatic switching between dual-chamber (DDD) and single-chamber atrial (AAI) pacing to reduce unnecessary stimulation when intrinsic conduction resumes. First- and second-degree blocks are tolerated up to a predetermined, programmable limit, and conversion to DDD takes place in the event of a high-degree AV block.

The effect is similar to that of Medtronic's managed ventricular pacing mode.

According to an ELA Medical news release, the reduction in pacing to 1% (a 40% reduction compared with standard pacemakers) may be beneficial because unnecessary pacing has been associated with an increased risk of heart failure and atrial fibrillation.

Minimization of ventricular pacing is expected to enhance patient comfort and also extend device longevity by two years.

The original Symphony AAISafeR device was approved for use in the EU in September 2003. It has not been approved by the FDA for use in the U.S.

VNS Therapy Systems (Models 102, 102R) for Pharmacoresistant Epilepsy in Korea and Brazil

On March 2, the Republic of Korea's Food and Drug Administration and the Brazilian Ministry of Health approved two implantable generator systems (Vagus Nerve Stimulation [VNS] Therapy models 102 and 102R, made by Cyberonics, Inc) for the treatment of pharmacoresistant epilepsy.

According to a company news release, the generators are slimmer, lighter, and easier to implant than the previous 101 models. The 102 generator system consists of the model 102 generator and model 302 single-connection lead. The 102R generator is a dual-connector version of the 102 model and is intended for replacement of model 100 and 101 generators with dual-connector model 300 leads that have reached end of service.

The devices are approved by the U.S. FDA for use as adjunctive therapy to reduce the frequency of seizures in adults and adolescents aged 12 years and older with partial onset seizures that are refractory to antiepileptic medications. This indication is also approved in the European Union (EU), Canada, Australia, and other countries.

In the EU and Canada, the VNS devices are also indicated for the treatment of depression in patients with treatment-resistant or -intolerant major depressive episodes, including unipolar depression and bipolar disorder. An approvable letter for this indication was granted by the FDA in February 2005.

Potential use of VNS for anxiety disorders, Alzheimer's disease, and chronic headache/migraine applications is being evaluated in clinical studies.

Reviewed by Gary D. Vogin, MD

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