A Medical Device Daily

Peak Surgical (Palo Alto, California) reported the first use of its Peak Surgery System by surgeons in the European Union, following receipt of the CE mark in January.

Raul Pellini, MD, and Professor Giuseppe Spriano, MD, ear, nose and throat (ENT) surgeons at Istituti Fisioterapici Ospitalieri (National Cancer Institute) in Rome, performed head and neck surgeries in cancer patients using the Peak PlasmaBlades.

Additionally, Spriano hosted a head and neck surgical course in May that included a live surgery using the PlasmaBlade.

"The PlasmaBlades worked beautifully in the partial laryngectomy and parotid dissection we conducted, producing nearly bloodless procedures," said Pellini. "We are very keen for our ENT colleagues to evaluate these innovative devices, as we expect that their patients will experience similar positive outcomes."

"Like their colleagues in the U.S., surgeons in Europe are providing positive feedback that the PlasmaBlade allows them to precisely cut tissue and control bleeding during a wide variety of surgical procedures without causing extensive collateral thermal damage to tissues," said Peak Surgical President/CEO John Tighe. "We expect to see continued uptake of the Peak Surgery System in Europe, where we believe the PlasmaBlade could eventually be used in more than 1 million surgical procedures annually."

The Peak PlasmaBlade is a family of disposable, low-temperature surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without the extensive collateral damage. The PlasmaBlade is part of the Peak Surgery System, which also includes the Pulsar Generator. The generator provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding.

In the U.S., the Peak Surgery System is cleared for use in general, plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. It was launched in the U.S. in July 2008 and has been used on more than 1,000 patients, including general, gynecologic, and plastic and reconstructive surgeries.

Peak Surgical has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the Peak Surgery System in plastic and reconstructive, gynecologic and oncologic surgery. Initial study results are expected later this year.

The PlasmaBlade family of devices offers the precision of a scalpel and the bleeding control of a traditional electrosurgery device in a single surgical instrument. The PlasmaBlade family includes the PlasmaBlade 4.0, which is designed to be used to cut through all types of soft tissue, including skin, fat and muscle; the PlasmaBlade Needle, which has a fine needlepoint tip and is specifically designed for ultra-precise surgical procedures; and the PlasmaBlade EXT, which is designed for use in surgical procedures requiring an extended-reach tip.

Peak Surgical's pulsed plasma-mediated discharges and electrode insulation techniques were originally invented at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University (Stanford, California) and developed by Peak Surgical.

Eli Lilly, Icon expand partnership

Icon (Dublin, Ireland), a provider of outsourced development services to the medical device, pharmaceutical and biotechnology industries, said it has signed a strategic partnership with Eli Lilly & Co. (Indianapolis) to manage the company's clinical trial site set-up and monitoring in Europe.

The agreement follows Lilly's selection of Icon to manage its clinical data management business outside of the U.S., which was announced in November 2008.

"[This] marks another milestone in the successful partnership between Icon and Lilly," said Icon CEO Peter Gray. "We have worked together to create a truly flexible model that better meets Lilly's patient and portfolio needs and will also drive productivity within Lilly's clinical operations in Europe."

Jeff Kasher, Eli Lilly vice president and COO of global clinical development, said, "This strategic agreement enables us to leverage Icon's significant expertise in clinical trial monitoring and site management in Europe and will increase our ability to speed innovative medicines to patients."

New software from TomTec

TomTec (Munich, Germany) has launched its 2D Cardiac Performance Analysis software as part of its CardioArena multimodality imaging solution at the American Society of Echocardiography congress in Washington.

2D Cardiac Performance Analysis allows cardiologists to study the behavior of the heart muscle quickly and easily. Quantitative assessment of displacement, velocity and strain in individual muscle segments is available. The diagnosis of pathologies like hypertrophic cardiomyopathy or dyssynchronous ventricles improves with this software and the decision for a cardiac resynchronization therapy is then more confident.

2D Cardiac Performance Analysis is a speckle tracking based analysis tool which can analyze 2-D data from various ultrasound machines. The user can utilize the data of different ultrasound systems and is not limited to specific vendors.

Already-acquired studies can also be analyzed with TomTec's 2D Cardiac Performance Analysis.

New chairman for DxS

DxS Ltd. (Manchester, UK), a personalized medicine company and developer of companion diagnostics, reported the appointment of Ron Long as chairman.

Long has 40 years' experience in both public and private companies, including leadership of the Wellcome Foundation and Amersham, where he was vice chairman.

He has served as non-executive director of DxS since July 2008 and replaces David Evans as chairman, who steps down. Long retains his positions at Medivir AB and Procognia Israel Ltd.

DxS has more than doubled in size in the last 12 months, with new manufacturing space taken at its Manchester site as a result of a global distribution deal agreed with Roche Molecular Diagnostics for its TheraScreen diagnostic kits, and a deal which has seen Amgen and Merck Serono/Bristol Myers Squibb use DxS' TheraScreen: K-RAS Mutation Kit as a companion diagnostic for the colorectal cancer treatment Vectibix and Erbitux.