A Medical Device Daily

CryoCath Technologies (Montreal), a maker of cryotherapy products to treat cardiac arrhythmias, has introduced its Arctic Front device in Italy, Belgium and Spain.

Arctic Front, the company's lead product for the treatment of paroxysmal atrial fibrillation (PAF), is a cryoablation balloon catheter that allows physicians to isolate all four pulmonary veins for the treatment of PAF.

"The introduction of Arctic Front in Italy, Belgium and Spain provides us with an exciting opportunity to deliver the benefits of our breakthrough therapy to a larger patient population," said Jan Keltjens, president/CEO of CryoCath. "By expanding our already strong presence in Europe, we are continuing to drive the adoption of [the] Arctic Front system worldwide."

Claudio Tondo, MD, chief of the cardiology division and director of the Cardiac Arrhythmia and Heart Failure Research Institute at San Camillo-Forlanini Hospital (Rome), performed the first procedures with Arctic Front in Italy on June 9.

Tondo said, "The cryo technology represents an effective alternative to radio frequency energy for safety reasons, prompting the extension of the ablative treatment to a larger population of patients suffering from PAF." The first Arctic Front procedures in Belgium were performed in May by Pedro Brugada, MD, head of the heart rhythm management center and Gian Battista Chierchia, MD, director of the atrial fibrillation and pacing program at UZ Brussel-Vrije Universiteit Brussel.

"We see great promise in the procedural simplicity of the Arctic Front System. The cryoballoon's innovative shape facilitates anatomical placement in the atrium at the ostium of the targeted pulmonary vein," said Brugada.

Julian Villacastin, MD, and his team at Hospital Clinico San Carlos (Madrid, Spain) first used Arctic Front on June 24. The two patients treated to date have had successful outcomes and no safety concerns have been reported.

Lab901, Seegene collaborate on tests

Seegene (Rockville, Maryland) and Lab901 (Edinburgh, Scotland) reported the availability of an automated multi-pathogen, walk-away detection platform for European hospitals. Based on technologies from each company, the new Seeplex/ScreenTape detection platform is being introduced to clinical and research laboratories in 10 countries across Europe.

The automated Seeplex/ScreenTape tests are based on a Seeplex multiplexing PCR technology from Seegene, which is capable of detecting multiple pathogens in a single tube, and ScreenTape, an automated walk-away gel electrophoresis detection system from Lab901.

Seegene and Lab901 have agreed to co-market the testing solutions in the European market. The companies said they are responding to requests in Europe for a new automated testing technique to perform what is a routine, but not always consistent, test for biological agents in clinics.

Hospital centers in the Netherlands, UK, Spain, Italy, Norway, Greece, Austria, France, Israel and Turkey have started demonstrations of the automated Seeplex/ScreenTape system.

"As active pathogenic surveillance becomes the norm for healthcare regimes worldwide, clinical research and reference labs will be placed under increased pressure to perform," said Dr. Jong-Yoon Chun, founder/CEO of Seegene. "It is essential that these labs gain the tools and systems that enable them to increase the speed and efficiency of pathogen detection."

Joel Fearnley, co-founder/CEO of Lab901, said, "The simplicity, speed and sample traceability of the Seeplex/ScreenTape system is clearly of real value to diagnostic microbiology and virology laboratories. The ScreenTape system optimized for Seeplex multi-pathogen tests will help speed up discovery and diagnostic procedures."

The Seeplex tests can be applied to a broad range of molecular diagnostics, and the ScreenTape system will automate the simultaneous analysis of eight or 16 Seeplex PCR samples. Processing speed for eight samples is completed within 10 minutes; 16 samples within 18 minutes.

The automated Seeplex/ScreenTape tests are currently available for sexually transmitted diseases, human papillomavirus, respiratory viruses and bacterial pneumonia. Additional tests are under development and will be available soon. Hospitals have shown particular interest for the single-tube Seeplex Sepsis test scheduled for release this month.

Adjustable breast implant introduced

Hilton Becker, MD, of Boca Raton, Florida, who has been working on creating breast implants for the last 20 years, has created what he said is his most effective implant yet — the Spectra Adjustable Gel Implant, which is 90% silicone and can adjust in both shape and size after it has been implanted.

"The biggest problem with patients is that they are disappointed with the shape and size of the breast after surgery," said Becker. "With this new implant you can, for the first time, change volume and projection postoperatively for several months using a silicone gel implant."

Since the implant is not FDA-approved, but is approved in Europe and Asia, it is being introduced there first through seminars and training.

Becker and his wife, Janet Cohen, RN, performed bilateral reconstruction surgery on two women who have had mastectomies, in front of a live audience of plastic surgeons, at the 7th Dusseldorf Breast Cancer Conference in Germany.

Then at the Scandinavian Association of Plastic Surgeons meeting in Aarhus, Denmark, Becker conducted a seminar on breast reconstruction and correction of congenital anomalies of the breast, and Cohen did a post-op care seminar for nurses.

Expansions move POC development forward

Vivacta (Sittingbourne, UK) said it is gearing up for pilot manufacturing of its highly sensitive, disposable piezofilm sensors for point-of-care (PoC) diagnostics by doubling its available space and appointing an experienced engineering manager.

The company acquired an additional 6,000 square feet of space within its Kent Science Park facility to allow it to establish a fully equipped Cartridge Pilot Facility. Vivacta said this will act as a process development resource for both its own development group and its technology licensees.

The new facility's main role will be to develop and optimize the process of cartridge manufacture as well as producing batches of up to 10,000 cartridges for internal evaluation and external clinical trials.