A Medical Device Daily

PEAK Surgical (Palo Alto, California) reported receipt of the CE mark for its PEAK Surgery System for use in general surgery.

The PEAK Surgery System includes the Pulsar Generator and the PEAK PlasmaBlade family of disposable, low-temperature surgical cutting and coagulation devices. The generator provides pulsed plasma radio frequency energy to the PlasmaBlade to incise tissue and control bleeding.

PEAK Surgical received 510(k) clearance from the FDA last July for the PEAK Surgery System for use in general surgery and in December for cutting and coagulation of soft tissue during plastic and reconstructive, ENT, gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures.

The company said that to date, surgeons in the U.S. have used the PlasmaBlade in more than 500 surgical procedures, including in general, gynecologic, cardiothoracic and plastic and reconstructive surgeries.

"We continue to receive positive feedback from surgeons in the U.S.," said John Tighe, president/CEO. "They not only find the PlasmaBlade to be intuitive and easy to use, but also to precisely cut tissue and control bleeding without extensive collateral thermal damage to tissues.

Tighe added, "We look forward to commercializing this innovative device in Europe, where we believe the PlasmaBlade could eventually be used in more than 1 million surgical procedures each year."

PEAK recently 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.

PEAK'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), then licensed and developed by the company.

CURE-AF study is expanded

Medtronic (Minneapolis) reported the expansion of its CURE-AF clinical program with a post-market study in Europe and Canada. Originally being conducted only in the U.S., the study is being carried out in order to secure FDA approval of the company's Cardioblate system for the investigational treatment of atrial fibrillation (AF).

The program will now collect post-market data internationally on the efficacy of irrigated cardiac ablation with radio frequency (RF) energy in AF patients.

The CURE-AF study is investigating the treatment of AF during an open-heart operation such as valve repair or CABG. During the procedure, a surgeon uses Medtronic's Cardioblate System to create a pattern of transmural lesions – lesions that span the full thickness of heart tissue.

The pattern of lesions is modeled after the highly successful Cox Maze procedure. The company said transmurality of the lesions is required for conduction block, which in turn is essential for the prevention of abnormal conduction associated with AF, and for the potential to restore normal heart rhythm.

The Cardioblate surgical ablation system achieves consistent transmural lesions with irrigated RF energy. It is currently indicated for cardiac tissue ablation, and has been used in more than 90,000 procedures worldwide.

Dr. Alexander Wahba, professor of cardiothoracic surgery at St. Olavs University Hospital (Trondheim, Norway), one of the new study participants, said, "We are delighted to be able to join this research effort. If successful in its objectives, CURE-AF will allow the introduction of a new treatment option for many patients who otherwise might endure an untreated arrhythmia and the considerable associated risks."

John Liddicoat MD, general manager of the Structural Heart Disease division in Medtronic's CardioVascular business, said, "AF is ... associated with a five-fold increase in a patient's likelihood of suffering a stroke which can frequently be debilitating and fatal, accounting for one in every 16 American deaths. The more data we have, the better placed we'll be to ensure that this unacceptably high number is reduced."

UK study eyes C. difficile 'code'

The British Midlands Development Corp. (Chicago) said that scientists at the University of Nottingham in the UK are leading a major European study to unravel the genetic code of one of the most lethal strains of hospital-acquired infections.

The $4.5 million, three-year study will use gene knock-out technology developed in Nottingham to study the function of genes in a "super" strain of the bacteria Clostridium difficile, to discover why it causes more severe disease, kills more people, is harder to eradicate and more resistant to antibiotics.

It is hoped that the study will lead to better tests to diagnose "super" strains of C. difficile, more effective treatments and, possibly, even a vaccine to protect against the disease. There is very little known about the ways in which the bacteria operate and why the strain should be more severe than its less virulent cousins.

Professor Nigel Minton of the University of Nottingham's School of Molecular Medical Sciences, who is leading the study, said, "These hypervirulent organisms seem to be taking over as the dominant strain in outbreaks and, worryingly, there are only two antibiotics which are still effective against them. There is a very real danger that total resistance may arise, and if that happens then this will become an extremely serious problem.

During the three-year study, scientists at Nottingham will use a technology called ClosTron to produce mutant versions of the hypervirulent strains. They will knock out genes one by one and then compare the mutant version to the standard organism to assess the function of each cell.

The Centre for Healthcare Associated Infections (CHAI) was established at the University of Nottingham in late 2006. CHAI consists of researchers from the university, together with clinical colleagues from Nottingham University Hospitals NHS Trust.

The British Midlands Development Corp. is the North American economic development agency for central England. The Midlands region is located one hour to the north of London and includes the major commercial centers of Birmingham, Nottingham, Coventry and Northampton. The region is at the heart of the UK's life sciences industry.

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