Boston Scientific (Natick, Massachusetts) reported regulatory approval and market launch in Japan for its Vitality DR implantable cardioverter defibrillator (ICD) system, which it said is the smallest dual-chamber ICD currently offered in Japan.

Boston Scientific said the Vitality DR system is based on the established Vitality line of products and “offers advantages for both patients and physicians.” For example, the size and shape of the Vitality DR (30 cc and 11 mm) is designed to facilitate ease of insertion and contribute to patient comfort.

The system incorporates AV Search Hysteresis (AVSH) programming — a feature that reduces right ventricular (RV) pacing when the heart’s natural rhythm is present.

“The INTRINSIC RV trial recently showed that dual-chamber ICD programming can provide benefits to patients such as improved heart function and enhanced arrhythmia detection,” said Peter Coenen, VP, Japan, for the company.

The company estimates that sudden cardiac death claims the lives of as many as 50,000 people a year in Japan. It says that more than 100,000 ICDs from the Vitality family have been implanted worldwide since the system was introduced in Europe in 2002.

EaglePicher reports progress on small implantable battery

EaglePicher Medical Power (Vancouver, British Columbia) last month reported the successful qualification of the Micro Battery, calling it the industry's smallest implantable-grade medical battery.

The company said the battery's size and shape (cylindrical, 0.260” long by 0.090” diameter) enables a device so small that it can be deployed via a minimally-invasive catheter procedure rather than traditional implantation surgery.

The device, currently undergoing clinical trials in Europe, is at least 50% smaller and lighter than known commercially available products, according to EaglePicher. The company said it is based on new cell construction developed by the company with electrical capacity that exceeds the original design objective by a factor of five.

The resulting battery theoretically can be powered for 15 years, according to the company. It said that the Micro Battery will create "new opportunities" for device makers in neurological catheters, cardiovascular monitoring and neural prostheses such as retinal and cochlear implants.

EaglePicher Medical Power supplies batteries to manufacturers of implantable medical devices, including batteries for cardio defibrillators, heart monitors, heart re-synchronizers and neuromodulation systems, among others.

Abraham, McCarthy investigators for C-Pulse trial

Sunshine Heart (Sydney, Australia) reported last month that William Abraham, MD, of Ohio State University (OSU; Columbus) and Patrick McCarthy, MD, of Northwestern University Feinberg School of Medicine (Chicago), would be co-principal investigators for the company’s C-Pulse feasibility trial in the U.S. “The participation of Drs. Abraham and McCarthy as co-principal investigators with their combined experience in the management of heart failure and expertise as clinical investigators will add great credibility to the C-Pulse trial within the international medical community,” said Donald Rohrbaugh, CEO of Sunshine.

C-Pulse is an implantable, non-blood contacting, mechanical heart assist device for the treatment of heart failure. The C-Pulse Cuff consists of a wrap and a balloon, placed around the aorta just above the heart. The balloon is inflated and deflated to the rhythm of the heart to improve blood supply to both the body and the heart muscle, while reducing the workload on the heart. The C-Pulse Driver is an external wearable unit that is linked by an air tube to the cuff and detects the heart’s natural rhythm and controls inflation and deflation of the balloon in rhythm with the heart.

Abraham has participated in more than 100 drug and device clinical trials and has been an investigator for several heart failure pacemaker trials of Medtronic (Minneapolis). He is a professor of internal medicine, division director of cardiovascular medicine and deputy director of the Davis Heart and Lung Research Institute at OSU.

McCarthy is the Heller-Sacks professor of surgery, division chief of cardiothoracic surgery and co-director of the Bluhm Cardiovascular Institute at the Feinberg School of Medicine. He has been a clinical investigator in trials of several heart assist devices and chairman of the Society of Thoracic Surgeons/American Association for Thoracic Surgery Joint Working Group on New Technology.

Oxford BioSignals moves to U.S. for future growth

Oxford BioSignals Medical (Oxford, UK) recently reported plans to move its global headquarters to the U.S. and expand its capacity for future growth. The new HQ will be in Carmel, Indiana, just north of Indianapolis. With the move, the company plans to create 120 engineering, clinical, technical, operational and commercial jobs within five years.

Frank Cheng, president/CEO, reported the company’s planned move along with Indiana Gov. Mitch Daniels, Carmel Mayor Jim Brainard and Daniel Evans Jr., president/CEO of Clarian Health (Bloomington, Indiana). The state of Indiana pledged more than $2.8 million in incentives, while the city of Carmel offered tax abatements totaling $116,000.

“We’re demonstrating again the ambition we have for Indiana to become a premier destination for companies in the life sciences industry, and the real progress we’re making to become a leader in this sector,” said Daniels.

A subsidiary of Oxford BioSignals, the company produces patient-safety software, known as BioSign, used by hospitals to better identify patients in a medical crisis.

BioSign received FDA clearance in 2006. It is being used in a clinical trial at Clarian Health’s Methodist Hospital (Indianapolis) and also being explored by University of Pittsburgh Medical Center.

Oxford BioSignals Medical also produces an electrocardiogram interpretation technology known as BioQT, which can help pharmaceutical companies, the FDA, and contract research organizations better monitor the cardiovascular effects of new drugs.

Atrium receives CE mark for ClearWay RX catheter

Atrium Medical (Hudson, New Hampshire) said it has received the CE mark for a new small-vessel therapeutic perfusion catheter, the ClearWay RX. The catheter is indicated for localized delivery of therapeutic agents to the coronary and peripheral vasculature.

The company said ClearWay RX is “the world’s first rapid-exchange therapeutic perfusion catheter for localized therapeutic delivery within small-caliber vessels. Delivering a smaller quantity of a preferred therapeutic agent locally has been shown to help reduce systemic effects.”

ClearWay RX is a low-pressure perfusion catheter incorporating a thin, semi-compliant microporous PTFE balloon material to deliver small quantities of medication. The microporous balloon allows for controlled infusion at very low pressures (2 atm to 4 atm) for maximum local therapeutic effect at a discrete targeted location.

The rapid exchange catheter is .014” guidewire-compatible, allowing access to difficult-to-reach target destinations throughout the body. ClearWay RX will be available in 1.0 mm to 4.0 mm balloon diameters and in balloon lengths ranging from 10 mm to 50 mm.

Canadian company selected to distribute HemoSense system

HemoSense (San Jose, California) said it has signed an agreement with ManthaMed (Mississauga, Ontario), a Canadian provider of monitoring and diagnostic testing technologies, to distribute HemoSense’s portable INRatio PT/INR monitoring system for patient self-testing and healthcare professionals in Canada.

The HemoSense INRatio system consists of a small monitor and disposable test strips providing measurement of blood clotting time, or PT/INR values, measurements necessary for the management of the patient’s warfarin dosing.

The company said the agreement with ManthaMed represents its 16th international distribution agreement and expands distribution to 23 countries.

Cook Medical receives Zilver approval in Canada

Cook Medical (Bloomington, Indiana) reported last month that its Zilver Vascular Stent system has received approval from Health Canada’s Therapeutic Products Directorate for treatment of symptomatic vascular disease of the iliac arteries with a reference vessel diameter of 6 mm or larger.

In February, Canadian authorities gave final approval for vascular use of Cook’s Zilver stent, a self-expanding nitinol device.

Cook says it now has regulatory approval to market the stent for vascular use in more than 25 countries, including the U.S. and Europe. Cook’s submission was supported by data from a 20-patient pilot study and a pivotal study evaluating 151 patients at 24 investigational sites. The stent is approved to treat lesions up to 100 mm in length.

Cook in February reported that the Zilver PTX Paclitaxel-Eluting Stent (DES) trial results demonstrated no stent fractures. Cook said that the major adverse event rate was equivalent to conventional balloon angioplasty treatment at its six-month follow-up point. To reduce or prevent restenosis, the Zilver PTX stent is coated with the drug Paclitaxel, approved for use as an anti-cancer agent. Paclitaxel-coated coronary stents are approved for use in the U.S. to reduce the risk of restenosis of the coronary arteries.

Krell named GM of Abiomed in Europe

Abiomed (Danvers, Massachusetts) named Paul Krell general manager for its European operations, based in Aachen, Germany. He joins Abiomed from ev3 Europe, most recently as VP, Europe, in its Neurovascular Division.

Krell has more than 14 years of experience in the medical device industry, including tenure at Guidant, where he held several management positions, including country manager in Germany for cardiac surgery products and European marketing manager for tachyarrhythmia products.

Abiomed manufactures products designed to assist or replace the pumping function of the failing heart, including the AB5000 Circulatory Support System and the BVS 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The company also has developed the AbioCor Implantable Replacement Heart.