A Medical Device Daily

Kinetic Concepts (KCI; San Antonio, Texas) reported that it has been informed by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan that in October the Ministry of Health, Labor and Welfare (MHLW) will grant regulatory approval for KCI to begin market development activities in Japan for its V.A.C. therapy product.

"This is exciting news for the medical community and patients in Japan," said Catherine Burzik, KCI president/CEO. "Our vision is to transform wound care in Japan by delivering advanced healing solutions and clinical know-how in a way that produces unparalleled outcomes."

The company anticipates that in October the MHLW will review that all necessary regulatory steps have been addressed before the application is taken to the Minister's Office for signature.

Following regulatory approval this fall, KCI said it anticipates reimbursement approval in the first half of 2010. Once reimbursement approval is obtained, KCI will begin commercializing V.A.C. therapy in Japan.

NI gets FDA approval of LSVD detection device

NI Medical (Kfar Mallal, Israel), a privately held biotech company, reported that it has received FDA approval for its NICaS CS, a new device for the assessment of left ventricular systolic dysfunction (LVSD), which helps doctors to detect heart failure in its pre-clinical, asymptomatic phase.

The basic NICaS device uses impedance technology for measuring fundamental cardiac functions like cardiac output, cardiac index, cardiac power, stroke index, total peripheral resistance, etc. The company said this device is characterized by exceptionally accurate results, revealing a bioequivalence with the thermodilution technique.

A new algorithm, the Granov Goor Index (GGI), has recently been added to the NICaS, now called NICaS CS. By adding this new apparatus to primary care physicians' personal kits, they will now be able to detect LVSD in the pre-clinical or asymptomatic phase during an ordinary physical examination in their offices.

The introduction of the GGI to medicine is of specific relevance to a certain fraction of coronary deaths called sudden cardiac death (SCD). SCD has had no therapeutic progress for the last half century.

Of the total 650,000 annual deaths from coronary heart disease in the U.S., about 350,000 succumb to SCD. The main cause of SCD, a condition called hibernating myocardium, accounts for about 35%-40% of the 350,000 cases of SCD.

"By detecting these 'hibernating' cases in a timely manner, most of the lives of these individuals can be saved," said Daniel Goor, MD, chairman and chief investigator at NI Medical.

To use the NICaS, a doctor, nurse, or medical technician simply places one double electrode on the patient's wrist and one on the ankle, meaning the patient need not undress, nor be shaved. The entire process requires only three to four minutes.

The NICaS electrodes are connected to the impedance device, which is situated within a laptop computer in place of the CD-ROM, and the laptop's screen serves as the monitor.

The Framingham Study determined the diagnostic parameters of the so-called asymptomatic LVSD in 2003. It was because of the high economic burden of screening the population for the treatment of this malady that this enterprise was abandoned. However, with the advent of the GGI, which proved that the parameters determined by the Framingham Study are accurate, and the nominally priced NICaS CS, at least 40% of asymptomatic LVSD cases will now have the opportunity for diagnosis and cure, according to the company.

"The prevalence of asymptomatic LVSD is age-related," concludes Prof. Goor. "Once this exam becomes routine in patients over 60, its impact on life salvation will be dramatic."

Integra reports 1st implant of DRT in Japan

Integra LifeSciences Holdings (Plainsboro, New Jersey) reported the first clinical implant of Integra Dermal Regeneration Template (DMT) in Japan. The operation was performed by Hajime Matsumura, MD, of Tokyo Medical University Hospital. DMT obtained Seizo Hanbai Shonin approval from the Japanese Regulatory authorities in 2008 for the treatment of deep second- and third-degree burns (life-threatening burns). It is distributed in Japan by Century Medical.

DMT was the first regenerative product approved by the FDA for the treatment of life-threatening burns and scar revisions. Since gaining the initial FDA approval in 1996, it has been used successfully on more than 100,000 patients, and is sold worldwide in over 40 countries.

DMT is an advanced bilayer skin replacement system, designed to provide immediate wound closure and permanent regeneration of the dermis. The inner layer is placed in direct contact with the excised wound and consists of a complex 3-dimensional porous matrix that acts as a scaffold for cell migration and allows for regeneration of the dermal layer of the patient's skin. The outer layer is a thin silicone film that protects the regenerative matrix and the wound from infection and controls both heat and moisture loss. Once the dermis has regenerated, the silicone outer layer is removed and replaced with a thin epidermal skin graft, providing the patient with their own flexible, living skin.