A Medical Device Daily

Heritage Worldwide (La-Seyne-sur-Mer, France), which bills itself as a “top-three” provider of breast implants internationally, reported that its subsidiary, Poly Implant Protheses, has been awarded approval by the Brazilian Sanitary Surveillance Agency to market gel-filled breast implants in that country, the world’s second-largest market for the devices.

“Not only is Brazil the second largest market for breast implants in the world, we expect to be the only one of the top three suppliers worldwide to have a significant position” in Brazil, said Jean-Claude Mas, chairman of Heritage. “Brazil, with a population of more than 175 million, is an ideal market for our products. We have won praise from many Brazilian surgeons for our asymmetric breast implants, which emphasize natural aesthetics and contours, and are . . . a significant improvement over existing products currently available in Brazil.”

He estimated the Brazilian breast implant market at about 70,000 pairs, and the expectation that the company will obtain up to a 10% share in the next 12 months.

“Securing Brazilian market approval is a significant step for us, and an important opportunity for us to be a strong international supplier in a large and growing market,” said CEO Alain Serreyjol-Garros. “Even though it took us two years to obtain this approval . . . in the last 12 months we have opened several new markets, and we are only at the top of the second inning of our game regarding our international expansion.”

Heritage said it has seen a “marked uptrend” in the market recently, and reported a 75% increase in revenues in its most recent quarter, plus “a strong turnaround to profitability.”

The company and its subsidiaries manufacture breast and other body implants and body support products worldwide. It maintains its production facility and headquarters in the Toulon metropolitan area in Southern France and a distribution facility in Spain. The company is incorporated in Delaware.

Zoll wins two international approvals

Zoll Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and software, reported receiving international regulatory approvals for two products: the Power Infuser from its Infusion Dynamics division, and the AutoPulse Non-invasive Cardiac Support Pump.

The Power Infuser, a miniature fluid resuscitation pump, has been granted approval by the Canadian Regulatory Agency, Health Canada Therapeutic Products Directorate, and it has the CE mark. To qualify for the CE mark, the Power Infuser was tested to international standards for electrical safety and electromagnetic compatibility. This testing is in addition to rigorous electromagnetic, climatic, altitude, vibration, and human-factor tests previously conducted by the U.S. Army and U.S. Air Force, which qualified the device for use in military aircraft, Zoll said.

Additionally, the AutoPulse has received approval from Australia’s Therapeutic Goods Administration, allowing for the sale and marketing of the AutoPulse to help treat sudden cardiac arrest in that country. The AutoPulse already has the CE mark, as well as regulatory approvals in Canada and New Zealand.

“These additional approvals expand the markets where Zoll can sell its advanced resuscitation products and should help to continue the progress made in international sales last quarter,” said Richard Packer, president and CEO. “Zoll remains focused on advancing the practice of resuscitation worldwide by offering a range of products that work together and help healthcare professionals save lives.”

Zoll bills the AutoPulse Non-invasive Cardiac Support Pump as “revolutionary in its design and potential to offer better outcomes.” As an adjunct to CPR, the AutoPulse does chest compressions that humans can’t do, while moving much more blood, more effectively to the heart and brain. The device consists of a backboard and a simple LifeBand that fastens across a victim’s chest, and it compresses the entire chest in a “hands-free” manner.

Zoll’s Infusion Dynamics division manufactures the Power Infuser, a lightweight device which provides rapid, controlled delivery of intravenous fluids to trauma victims. The pump delivers controlled fluid boluses at rates up to 100 ml per minute – several times that of conventional infusion pump – but is small enough to strap to a patient’s arm.

Primarily sold to the military, the product has applications in aeromedical transport, EMS, and emergency room settings. Infusion Dynamics (Plymouth Meeting, Pennsylvania) and the Walter Reed Army Institute of Research (Silver Spring, Maryland) jointly conceived the Power Infuser to treat wounded soldiers on the battlefield and in transport.

With products for pacing, defibrillation, circulation, ventilation, and fluid resuscitation, Zoll also designs and markets software that automates the documentation and management of both clinical and non-clinical data. The company has operations in the U.S., Canada, the UK, Germany, France, the Netherlands, Australia, and Austria.

HP reseller for Precision Dynamics

Precision Dynamics (PDC; San Fernando, California), a developer in automatic wristband identification, reported signing a reseller agreement with Hewlett-Packard Taiwan to accelerate the adoption of radio frequency identification (RFID) solutions in the Taiwan healthcare market.

HP Taiwan is granted an exclusive license to offer PDC RFID Wristbands, including Smart Band, SuperBand, ScanBand, CompuBand, and Smart AgeBand, as part of its healthcare information technology offering to hospitals in Taiwan.

The RFID solution will initially be targeted for use in operating rooms of hospitals implementing systems for preventing medical errors.

“Our collaboration with HP Taiwan is an important step for PDC as it significantly extends our ability to deliver solutions to customers in Asia,” said Gary Hutchinson, PDC president and CEO.

“As a result of our alliance with PDC, we are creating robust RFID solutions that will help prevent medical errors in hospitals,” said Mingpey Chou, HP Taiwan RFID Initiative Lead.

PDC and HP Taiwan reported that they also have begun RFID implementation at Keelung Chang Gung Memorial Hospital in Taiwan. During the initial phase, PDC Smart Band RFID Wristbands will be used in operating rooms to identify the right patient, right surgical site, right nurse, right blood and right doctor, an added safety check intended to help reduce human errors and enhance the patient safety. The companies said that this is the first RFID implementation resulting from the reseller agreement.

PDC calls itself “the global leader and pacesetter” in the development of automatic identification wristband systems. It says that it introduced the first patient Bar Code ID Wristband System in 1984, the Smart Band RFID Wristband System in 2000 and the AgeBand Electronic Age/ID Verification System in 2004. PDC also provides products for labor and delivery, urology and other health applications.