A Medical Device Daily

Big aesthetics player Mentor (Santa Barbara, California) yesterday reported that has agreed to acquire all of the outstanding shares of Perouse Plastie (Bornel France), a manufacturer of silicone gel breast implants.

Mentor will pay 142 million to acquire all of the shares of Perouse, including the assumption of about 13 million Euros in debt. The purchase price is subject to post-closing adjustments and indemnifications.

The acquisition is expected to be completed in July. Terms of the deal, expect Perouse distributes its breast implants to international markets, selling its products under the Perouse Plastie Perthese brand. Its primary manufacturing facility is located in France.

“This acquisition will increase our leadership in several international markets and represents our commitment to expanding our market presence in the surgical aesthetics field,” said Joshua Levine, President/CEO of Mentor. “The Perouse product offering is complementary with Mentor’s aesthetic products and the combination will allow us to better serve physicians and their patients.”

Mentor said it will update its financial guidance for FY08 and provide an estimate of costs that may be excluded from adjusted earnings per share at the time of Mentor’s 1Q08 earnings release.

Mentor said it does not believe that the Perouse acquisition will have any material effect on FY08 adjusted earnings per share.

“Perouse has manufacturing capabilities which will expand our capacity and ability to meet growing customer demand for silicone gel breast implant products worldwide,” said Ed Northup, VP and COO of Mentor. “Perouse’s focus on product quality and customer service makes this a very complementary fit with our breast implant business.”

Medtronic launches CareLink in Europe

Medtronic (Minneapolis) reported the European launch of its CareLink heart monitoring system at this week’s Europace meeting in Lisbon, Portugal, terming the development “a major step forward” in medical device technology.

The company said the CareLink network, monitor and software “will enable patients at risk of heart conditions to electronically transmit data from their implanted cardiac device directly to their physician, allowing the completion of life-saving check-ups without [leaving] home.”

“The launch of CareLink is a major milestone in the management of heart conditions, and represents an important advance in the ongoing care of patients with implantable devices,” said Dr. John Morgan, professor of cardiology at Southampton University (Southampton, UK). “The facilitation of a remote service will free up vital time to improve the patient’s quality of life, and provide more choice and flexibility for patients. It also will offer the peace of mind that comes from knowing that expert care is only a phone call away.”

Medtronic cited statistics showing that about 500,000 patients die from sudden cardiac death (SCD) in Europe each year, most deaths caused by arrhythmias that are triggered by a fault in the heart’s electrical system.

Implantable cardioverter-defibrillators (ICDs) are implanted in the chest area with leads extending to the heart, where they administer electrical therapies to stop the ventricular arrhythmias that can lead to sudden cardiac death. Medtronic said that up to 2 million patients in Europe are candidates for ICDs, which have been proven to be 98% effective in preventing SCD.

Noting that patients with ICDs need regular check-ups to monitor the function of their devices, the company said the CareLink Network connects such patients and their physicians via the Internet for “virtual check-ups.”

Patients simply hold a small antenna over their device; information on how their heart and ICD are working, which is comparable to the information provided during an in-clinic follow-up visit, is downloaded into the CareLink Monitor.

The information is then sent through a telephone line directly to a new data center in Europe, where clinicians can access their patients’ data by logging onto a secure physician Web site, and may make adjustments to the patient’s medication or prescribe additional therapy without needing to see the patient in person.

Medtronic said that people living with an ICD face two to four scheduled visits to their clinic each year for a device check-up, with unscheduled visits as needed for more critical situations. “Now, the ... CareLink Monitor allows patients to stay connected to their clinicians from their home, from work or while traveling, potentially meaning fewer clinic visits,” said the company.

The CareLink Network benefits physicians, allowing them to quickly and thoroughly review the status of a patient’s heart condition, and schedule follow-up appointments when necessary. “This creates vital extra time to counsel patients with more critical conditions, ensuring medical efficiency and better overall patient management,” Medtronic said.

The CareLink Network also may result in reduced emergency department and unscheduled clinic visits, according to the company. It said the network is the first and only system to allow remote monitoring and alerting of fluid buildup in the thoracic cavity, via the OptiVol Fluid Status Monitoring feature available on select ICDs, which Medtronic said potentially will prevent heart failure hospitalizations.

“This technology allows us to extend the reach of cardiovascular patient care beyond the clinic walls and opens up a new way for physicians to treat patients, with the potential for more efficient chronic disease management and better patient outcomes,” said Peter Steinmann, vice president-Western Europe for Medtronic’s Cardiac Rhythm Disease Management business. “The CareLink Network is a tremendous convenience for patients and clinicians, and allows patients more security and peace of mind about their devices.”

The Medtronic CareLink Network already is used by more than 130,000 patients in the U.S.