A BB&T

Bausch + Lomb (B+L; Rochester, New York) in December reported that it has acquired 100% of the outstanding shares of Laboratorio Pfortner Cornealent SACIF, the controlling entity of Waicon (Buenos Aires, Argentina). The terms of the agreement were not disclosed.

B+L said the Pfortner family will continue to operate their retail chain of optical shops under the brand name Pfortner and as an independent company, unrelated to B+L.

While B+L plans to combine Waicon with its Vision Care operations in Argentina, the businesses will continue to operate separately as the companies proceed through the integration process.

Waicon is an excellent strategic fit for Bausch + Lomb, with complementary offerings, a long-standing and trusted brand, a rich heritage and a shared commitment to customer service, said Mariano Garcia-Valino, EVP and president, Bausch + Lomb Latin America. Together, we will create the most innovative and comprehensive eye health portfolio in Argentina, offering eye care professionals and patients unprecedented choice when it comes to meeting their needs.

With broad channel coverage and direct distribution capabilities, Waicon will deepen B+L s customer access and accelerate its business expansion in this growing market. Likewise, by investing in innovative new technologies, B+L will maximize the value of Waicon s existing products, while unlocking a pipeline of new products for the Argentinean market.

St. Jude reports first implant in trial for Portico valve

St. Jude Medical (St. Paul, Minnesota) reported the first implant of its Portico transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE mark approval. The trial will study the safety and effectiveness of the Portico heart valve for patients with severe symptomatic aortic stenosis who are at high risk for conventional open-heart valve replacement therapy.

The trial is a non-randomized study that will take place at five European centers, and will enroll a minimum of 30 patients who will be followed for one year. The primary endpoint is 30-day all-cause mortality, with secondary safety and effectiveness endpoints. Ganesh Manoharan, MD, of Royal Victoria Hospital (Belfast, UK) is the principal investigator for the trial.

Based on our experience implanting the valve during our feasibility study, and the positive patient outcomes we have seen in those patients, we are looking forward to studying the use of this next-generation technology with additional patients, said Manoharan, who implanted the first patient in the trial.

The Portico valve, with leaflets made of bovine pericardial tissue, is designed to increase physicians control and placement accuracy during valve deployment. The Portico transcatheter heart valve can be completely resheathed, allowing physicians to reposition the valve at the implant site or retrieve the valve, before it is released from the delivery system, an advancement over current-generation transcatheter valves.

The Portico transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. While the trial will study the 23 mm Portico valve and transfemoral delivery system, both transfemoral and transapical approaches are ultimately expected to be possible with the Portico valve portfolio.

Nonin reports European launch of sensor

Nonin Medical (Minneapolis) reported the European launch of a pediatric sensor for use with the company s Equanox regional oximetry system.

The Equanox Advance Model 8004CB Sensor is the first single-sensor solution on the market for patients under 40kg, according to the company. The 8004CB sensor is designed for use across neonatal and pediatric populations who require accurate oxygen saturation monitoring of cerebral and other tissues in diverse treatment settings. Nonin s complete Equanox Advance sensor line, which also includes the Model 8004CA sensor for adults, provides inherent absolute accuracy, reducing the need for complex and time-consuming patient-specific setup.

Zimmer establishes Asia-Pacific R&D center

Zimmer (Warsaw, Indiana) reported last month at the Chinese Orthopaedic Association (COA) international congress that it will establish a new R&D center in Beijing, China. The center will lay the foundation for a network of R&D programs across the region.

The Asia-Pacific region offers significant growth opportunities in both established and emerging markets, said David Dvorak, president/CEO of Zimmer. Investment in local research and development represents a critical component of Zimmer s long-term strategy to provide clinically-relevant offerings for Asian markets.

Zimmer s Beijing-based research and development will be involved in collaborative efforts with local engineers and healthcare professionals with the goal of developing products and technologies to meet needs of Asian patients and healthcare providers.

Paramit completes deal with Lemarne

Paramit (Morgan Hill, California), a provider of devices and instrument manufacturing services, reported in December that it has completed a deal with Lemarne (Melbourne, Australia) to purchase its Malaysian based manufacturing organization Lemtronics. Paramit had previously reported in October that it had entered into an agreement with Lemarne to purchase Lemtronics.

The sale was approved by Lemarne s shareholders at a general meeting Nov. 24.

This acquisition expands our global footprint and gives us a vehicle to offer medical device and instrument manufacturing services to our current and future customers for the Asian and European markets, said Paramit CEO Billoo Rataul. We see a tremendous potential to service our customers worldwide.

Paramit is a portfolio company of Altaris Capital Partners.

CardioInsight gets CE mark for its Ecvue system

CardioInsight Technologies (Cleveland) in December reported CE mark clearance and the European commercial launch of its Ecvue system to aid in the diagnosis of cardiac arrhythmias. In conjunction with this commercial launch, the company reported that it has secured its first three clinical customers, which include Wyn Davies, MD, at St. Mary s Hospital (London), Heinz-Friedrich Pitschner, MD, at the Kerckhoff Heart and Lung Center (Bad Neuheim, Germany), and Michel Haissaguerre, MD, at Hopital Cardiologique du HautLeveque (Bordeaux, France).

CardioInsight s Ecvue technology gathers electrical information from an electrode vest placed on a patient s body and combines the information with images from a CT scan to produce 3-D electrical maps of the patient s heart. The company claims that this is the first non-invasive, real-time, single beat, mapping solution to potentially improve the diagnosis and treatment of electrical abnormalities of the heart, including cardiac arrhythmias and congestive heart failure.

To date, CardioInsight has completed more than 390 patient studies at clinical centers in the U.S. and Europe. These studies address a broad variety of cardiac arrhythmias, as well as cardiac resynchronization therapy for congestive heart failure, demonstrating the unique clinical value of the Ecvue system.

CardioInsight is commercializing a technology called Electrocardiographic Mapping (ECM) that non-invasively generates 3-D images of the electrical activity of the heart. The images help physicians more accurately treat certain heart ailments such as arrhythmias and congestive heart failure.

ECM non-invasively generates real-time, whole heart images of the electrical activity on the surface of the heart by combining body surface electrical data with 3-D anatomical data obtained from imaging scans. The Ecvue system reconstructs and displays 3-D images and other useful measures of cardiac electrical activity as if the measurements were taken directly from the surface of the heart.

Inova receives CE mark for LifeChoice system

Inova Labs (Austin, Texas), a device company developing products for the chronic obstructive pulmonary disease (COPD) market, reported last month that it had received CE mark approval to begin marketing the LifeChoice portable oxygen concentrator system in Europe.

This is a major milestone for our company and for COPD patients who are on long term oxygen therapy, said John Rush, CEO of Inova Labs. The LifeChoice technology allows patients to continue to live their daily lives with minimal disruption despite the advanced stage of their COPD disease.

The company said it is in discussions with potential partners in Europe and expects to begin marketing the LifeChoice technology in the region in early 2012.

LifeChoice delivers oxygen to the COPD patient using a proprietary Pulse Wave technology, which insures that the patient receives maximum benefit from the oxygen produced. LifeChoice also offers Auto Mode technology which enables the patient to automatically receive the prescribed oxygen dose during periods of activity as well as sleep. The product is approved by FAA for air travel and is manufactured under strict ISO certification guidelines.

LDR markets VertiBridge spinal products in China

LDR (Austin, Texas) has received approval to market two new spine device systems in China. The ROI-C Cervical Cage and the ROI-A ALIF Cage, both featuring VerteBridge Plating Technology, and with more than 17,000 implantations combined worldwide, are now available to Chinese surgeons.

The ROI-C Cage for the cervical spine and the ROI-A ALIF Cage for the lumbar spine address the growing interest in the market for stand-alone fusion technology that may reduce the need for additional anterior or posterior instrumentation. Both cages, when used with the company s integrated VerteBridge plating technology, offer a zero profile, stand-alone fusion construct.

Christophe Lavigne, CEO of LDR, said, China is one of the fastest growing device markets today and represents a significant opportunity for LDR. Following the successful launch of the Mobi-C Cervical Artificial Disc into the China market in 2009, these new product approvals allow LDR to provide our surgeon customers in China with the best technology on the market today. LDR China has direct offices in Beijing and Shanghai to support the needs of our Chinese surgeon customers.

Korean hospitals to collaborate with Abu Dabi

The Ministry of Health and Welfare and The Korean Health Industry Development Institute (both Seoul) reported that the Health Authority-Abu Dhabi and four Korean hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Asian Medical Center and Seoul St. Mary s Hospital (all Seoul) have signed an agreement to collaborate in a patient treatment-reference system in Abu Dhabi.

The four Korean hospitals will send bills to the Health Authority-Abu Dhabi, within six months of providing medical services to patients. The Health Authority-Abu Dhabi will pay all bills in Korean currency through the UAE Embassy in Seoul within 45 days of a request being submitted. The Health Authority-Abu Dhabi is now selecting the first group of patients to come to South Korea. It is expected to dispatch patients from Abu Dhabi to the four Korean hospitals, possibly beginning early next year.

The agreement with the Health Authority-Abu Dhabi is a visible outcome of the efforts of the Korean Government to expand international cooperation in the area of healthcare and medicine and to promote the nation s medical institutions. South Korea and the UAE are expected to expand their cooperation to include diverse fields, such as the export of medical institutions and advanced healthcare systems based on the IT technology, which is one of South Korea s strong points, and training program for international doctors.

Estech begins enrollment in HISTORIC-AF study

Estech (San Ramon, California) reported in December that the first three patients have been enrolled in the HISTORIC-AF European multi-center staged hybrid ablation clinical study. Ten centers will participate in the study which is expected to enroll more than 100 patients in Italy, Germany, the UK, France, and Poland.

The HISTORIC-AF staged hybrid ablation study will enroll persistent and long-standing persistent atrial fibrillation (AF) patients who represent more than 50% of all AF patients in a two-step procedure. The first stage is a true minimally invasive endoscopic epicardial ablation utilizing the Cobra Adhere XL device to isolate the posterior left atrium via the highly efficacious box lesion. This unilateral procedure usually lasts less than two hours and is concluded with rigorous electrophysiological confirmation of conduction block in the operating or hybrid suite. A continuous loop monitor is implanted to continuously monitor the electrical activity of the heart. Four to six weeks later, the second stage is performed in the electrophysiology lab utilizing electrophysiological mapping and, if necessary, additional endocardial catheter ablation.

The HISTORIC-AF clinical study follows the extensive experience with this staged hybrid approach accumulated by Claudio Muneretto, MD, and Antonio Curnis, MD, at the Civil Hospital of the University of Brescia Medical School, Italy. We now have experience with almost 50 patients using this technology in a staged hybrid approach, and are very pleased with the safety and the results, said Muneretto. Teamwork between cardiac surgery and electrophysiology will be the key for successful treatment of this challenging disease. Our data indicate that even for the most difficult long-standing persistent AF patients, we have better than 85% freedom from AF throughout more than two years follow-up, confirmed by implanted continuous loop recorder data. We have found that the staged approach provides superior clinical success and more efficient workflow.

We are excited about the staged hybrid solution with the Estech platform which offers us many potential advantages, including a more comprehensive lesion set, better lesion assessment, shorter procedure times for each discipline, fewer complications, and ultimately better outcomes. This will allow us to treat a large population of AF patients previously thought unsuitable for catheter or surgical ablation alone, Curnis said.

Varian TrueBeam used for first time in France

A 19-year-old brain tumor patient became the first person in France to be treated using the TrueBeam radiotherapy treatment system from Varian Medical Systems (Palo Alto, California), the company reported last month. The male patient s cerebral glioblastoma was treated at the Cancer Research Center of Languedoc-Roussillon at the Centre Val d Aurelle (Montpellier, France). We believe that the system s dose delivery speed and its unique ability to image the patient during the treatment will bring considerable benefits for our patients, said Professor Jean-Bernard Dubois, head of radiotherapy. With TrueBeam we are able to image the tumor during the treatment and adapt the treatment delivery in real-time , which helps to better target the tumor and limit damage to surrounding healthy organs.

Designed to advance the treatment of lung, breast, prostate, head and neck, and other types of cancer, the TrueBeam platform for image-guided radiotherapy and radiosurgery is a fully-integrated radiotherapy system designed from the ground up to treat a moving target with speed and precision.

The Centre Val d Aurelle, which delivers radiotherapy treatments for 2,000 new cancer patients each year, was one of the first hospitals in France to introduce intensity modulated radiotherapy ten years ago and has now become the first to offer TrueBeam treatments.

Xeltis begins first study of new cardio grafts

Xeltis (Zurich, Switzerland) reported conditional approval by the Paul Erlich Institute (PEI; Langen, Germany) to commence the first clinical study of its tissue-engineered cardiovascular grafts. The prospective, single-center study will evaluate the safety and efficacy of Xeltis autologous tissue-engineered vascular grafts in pediatric patients requiring completion of a total cavo-pulmonary connection (TCPC). Sponsored by the University of Zurich, the trial will include up to 10 patients and will be performed at Heart Center (HZL; Leipzig, Germany).

Xeltis designed its tissue-engineered implants to address a significant unmet clinical need in cardiovascular therapies. Today s grafts are made of artificial material or of animal tissue, both having significant limitations such as potential rejection, limited durability and calcification over time. In contrast, Xeltis implants are regrown from the patients own cells. The resulting implants are, therefore, designed to behave like native organs, with unlimited durability, no risk of rejection and no need for anticoagulants. In addition, children implanted with today s grafts face the critical problem of outgrowing their implants, requiring them to undergo one or more reoperations, each with an increasing rate of morbidity. Because Xeltis implants have the ability to grow as the child grows, they may remove the need for reoperations.

Xeltis anticipates first patient enrollment in the study in 2012. Results of the trial will be used towards approval by the European Medicines Agency under the Advanced Therapy Medicinal Products regulation. Xeltis is funded by private investors and the Cantonal Bank of Zurich.

Ascendx inks sales accord in France

Ascendx Spine (Winter Park, Florida, which recently received CE mark approval for its Ascendx VCF repair system and its Acu-Cut vertebral augmentation system to treat vertebral compression fractures (VCF), reported that it has engaged Paris-based distributor Spinaxis to launch the company s sales efforts in France.

We expect to announce additional distributor relationships in Europe very soon. We are very focused on market penetration throughout Europe of our Ascendx VCF Repair system and the Acu-Cut vertebral augmentation system, which are designed for the treatment of spinal fractures by spine surgeons and interventional radiologists, said Julian Mackenzie, CEO of Ascendx.