Medical Device Daily European Editor s

The University of Leipzig Heart Center (Leipzig, Germany) has successfully performed the first placement of a Sapien XT aortic heart valve from Edwards Lifesciences (Irvine, California) using the company's Ascendra 2 transapical delivery system.

"The Ascendra 2 system makes the transapical procedure easier and faster, which should result in broader surgeon and patient access to this approach," said Thomas Walther, MD, who performed procedure.

Europe has provided Edwards with a robust proving ground for its transcatheter heart valve system with products commercially available for both transfemoral and transapical valve delivery (Medical Device Daily, June 29, 2009).

The majority of Edwards valves are delivery transapically via a small incision between the ribs and the new Ascendra 2 system improve on the existing system with a slimmer introducer catheter to minimize trauma and blood loss during the beating heart procedure.

Sapien XT, a new leaflet shape aortic valve with a cobalt chromium alloy balloon-expandable frame, is set for evaluation in the PREVAIL clinical toward the goal of CE-mark approval expected for 2010 (MDD, May 29, 2009).

The Leipzig Heart Center patient is the first to be enrolled in that trial.

Ziehm, BrainLAB integrate tech for spine surgery

Two German medical technology companies Ziehm Imaging (Nuremberg) and BrainLAB (Munich) have agreed to expand their cooperation for trauma and spinal operations.

A new flat-panel detector technology from Ziehm producing immediate high-resolution 3-D images from the company's mobile C-arm Vision FD Vario 3-D will be integrated with the surgical navigation of BrainLAB.

Digital datasets from X-ray images sent by the Ziehm NaviPort interface are imported to the Fluoro 3D navigation software from BrainLAB that automatically matches the C-arm dataset taken during the surgery with the unique anatomical structures of the patient without additional steps required for registration.

This capability allows the surgeon to follow the patient's anatomy and the movements of the surgical instruments on the monitor in real time during the operation.

The Department for Trauma, Reconstructive and Plastic Surgery at Leipzig University Clinic are the first to use this new technology.

A study at Rostock University Clinic shows that pedicle screws used in spine surgery can be positioned more precisely with the aid of the 3-D C-arm X-rays. Intraoperative monitoring also reduces or eliminates post-operative CT scans superfluous.

Flat-panel detectors for mobile fluoroscopy can display images with more than 16.000 shades of grey, four times greater than conventional image converters, improving soft tissue imaging along with visualization of bony anatomy.

With 3,300 systems installed in more than 75 countries, BrainLAB is a market leader in image-guided technology for navigation during surgical procedures.

St. Jude launches next generation PCN

St. Jude Medical (St. Paul, Minnesota) reported the European launch of the next generation of the patient care network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices. PCN gathers and stores data from the implant procedure, in-clinic follow-up visits and from remote transmissions sent from a patient's home. Remote transmissions can include both patient-initiated and automatic follow-ups and monitoring transmissions sent via a Merlin@home remote transmitter. In addition to giving physicians more timely access to important patient and device data, the wireless monitoring system is designed to allow physicians to compile a more complete patient record by transferring cardiac device data into electronic health record (EHR) systems.

The newest version of PCN, version 4.0, supports all radio frequency (RF) St. Jude ICDs, non-RF Epic ICDs, Atlas ICDs, Current ICDs and Promote CRT-D devices, and now also supports the Accent RF pacemaker and Anthem RF CRT-P (cardiac resynchronization therapy pacemaker). The Accent RF and Anthem RF product families use RF telemetry that enables secure, wireless communication between the implanted device and the device programmer or Merlin@home transmitter. The remote monitoring capabilities of these devices, facilitated by the PCN, permit automated hands-free follow-up, and daily device safety checks with no patient interaction required.

The latest version of the PCN also features the DirectTrend Viewer reporting capability, which can be used to enhance visibility into patient trends to simplify patient management and enhance clinical insight. The DirectTrend Viewer reporting feature allows physicians to track data over time related to clinical events, alerts, and recent transmissions.

"Our focus with this next-generation system continues to be on giving physicians timely, actionable data, and improving disease management," said Eric Fain, MD, president of the St. Jude Medical Cardiac Rhythm Management Division.

"Adding the DirectTrend Viewer Reporting feature helps improve the speed at which physicians receive and can interpret information, so they can effectively manage their patients' conditions."