A Medical Device Daily

ExThera Medical (Berkeley, California) reported that the results of a preliminary study of its proprietary medical device, Seraph extracorporeal affinity therapy, have been published in the current issue of the Journal of the American Society for Artificial Organs (Jan.-Feb. 2010).

The company said that one very important clinical application of Seraph (Selective Removal by Apheresis) is expected to be the treatment of sepsis within intensive care units. Seraph consists of a specially designed cartridge packed with a bioactive polymer substrate that acts as a hemofilter. By incorporating immobilized heparin, the cartridge's high-surface-area can safely and selectively reduce cytokine levels and remove certain pathogens from a patient's blood before the blood is (re)infused.

In the study conducted at the Karolinska Institute (Stockholm, Sweden), when blood from septic patients was passed through a miniature version of the Seraph cartridge, concentrations of pro-inflammatory cytokine tumor necrosis factor-a (TNF-a) were "significantly reduced from initially very high levels." In the control group, passage of blood from septic patients over non-heparinized beads did not affect the TNF-a levels. "We conclude that surface heparinization may be a useful technique for selectively regulating the levels of heparin-binding cytokines from whole blood. This may have implications for the treatment of hyper-inflammatory conditions such as severe sepsis," said principal investigator Jonas Axelsson, MD, PhD, of Karolinska Institute's Department of Renal Medicine.

SafeStitch gains CE mark for AMID Stapler

SafeStitch Medical (Miami) reported that it has received CE mark authorization to commercialize its AMID Stapler. The new stapler is to be used for fixation of mesh in the repair of hernia defects and also for the approximation of tissues, including skin. The AMID Stapler is the first surgical stapler designed specifically for use in inguinal hernia repairs using the Lichtenstein method, in which mesh is implanted for reinforcement. SafeStitch said in November 2009 that it had received 510(k) clearance from the FDA for sale of the AMID Stapler in the U.S. market.

SafeStitch designed the stapler in collaboration with Parviz Amid, MD. Charles Filipi, MD, SafeStitch's medical director and former president of the American Hernia Society (Englewood, Colorado), noted that "approximately one million hernia repairs are performed in the U.S. each year and the Lichtenstein repair is used in as many as 70% of inguinal hernia repairs worldwide. Based on clinical experience to date, we believe the AMID Stapler will make the Lichtenstein repair faster and more attractive to surgeons presently affixing mesh and closing incisions with sutures."

Merlin@home transmitter gets CE mark approval

St. Jude Medical (St. Paul, Minnesota) reported CE mark approval of its USB cellular adaptor for the Merlin@home transmitter, a system that allows important patient data from an implantable cardiac device to be wirelessly downloaded and securely transmitted via telephone for review by a physician. The new USB adaptor allows patients using a Merlin@home transmitter to transfer data to their physician over the cellular network, in addition to the existing landline service previously available.

The USB cellular adaptor is a small device that plugs into new and existing Merlin@home transmitters. The transmitter typically sits on a patient's bedside table and wirelessly communicates with the patient's device during the night. Regularly scheduled follow-up appointments and daily device checks occur without any patient interaction required. This connectivity allows patients to limit the need for unnecessary visits to their physician's office, but also allows physicians to more quickly become aware of any changes with the patient's condition or device.

The Merlin@home transmitter is transportable and can transmit device data from anywhere with a mobile signal or landline and electrical power. The transmitter supports all radio-frequency (RF) St. Jude Medical implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), and the Accent RF pacemaker and Anthem RF CRT-P (cardiac resynchronization therapy pacemaker). The Accent RF pacemaker and Anthem CRT-P are the first and only pacemakers that provide complete remote and in-clinic follow-ups via wireless communication. The data from these devices are transmitted from the patient to the physician via the Merlin.net Patient Care Network (PCN), an Internet-based repository of patient and device data.

Implantable cardiac devices are designed to capture and record information about device performance and patient heart rhythms that is vital to patient care. Merlin.net PCN organizes this information for fast analysis and easy review and allows data to be sent directly to a clinic's or a hospital's EHR system so the data can be included in the patient's comprehensive personal health record. Alerts can also be set up by the physician, based on their preferences, notifying them of any urgent changes with the patient's condition or device.

The company said that the data transferred using the Merlin@home device is fully encrypted and meets or exceeds all applicable national data privacy and security requirements in every country where the Merlin.net PCN is used.