“AlloMap is a valuable tool in the management of heart transplant patients,” said Dr. Howard J. Eisen, professor and chief of cardiology at Drexel University College of Medicine in Philadelphia. “As a simple blood test, AlloMap can be used on an ongoing basis to help to determine which heart transplant patients are the least likely to suffer from rejection, which is a key factor in the long-term well being and treatment of these patients.”

AlloMap Testing assays the RNA levels of 11 rejection biomarker genes and nine control genes. AlloMap Testing was clinically validated using data from 9 leading heart transplant centers participating in the Cardiac Allograft Rejection Gene Expression Observational (CARGO) study. AlloMap Test has been available since January 2005 as a Laboratory Developed Test (LDT) performed in the XDx Clinical Laboratory Improvement Amendments (CLIA) certified Laboratory, and has been ordered at more than 50 U.S. transplant centers. The AlloMap Test may be used for stable patients aged 15 years or older at any time after the second month post-transplant. In order to maintain tight control of the testing processes, AlloMap Test is currently performed only at the XDx Reference Laboratory.

Press release: XDx's AlloMap® Gene Expression Test Cleared by U.S. Food and Drug Administration (FDA)

Company page: XDx Expression Diagnostics

Presentation at the FDA: AlloMap® Molecular Expression Testing: A specific example of CLIA oversight ofa laboratory-developed test service (.pdf)...

System components from the product page:

The Epicor™ Ablation Control System (ACS) The ACS is designed for consistent, effective delivery of HIFU energy. It features an intuitive user interface, single-button control of ablation cycles, and convenient storage and recall of procedural and system information. Three generators provide consistent three-phased ablative energy through all layers of tissue, without concerns for tissue depth or the need for fat dissection.

The UltraCinch™ Ablation Device – The UltraCinch device enables creation of a uniform, continuous, linear lesion during cardiac ablation. It can be placed securely around the patient's atrium while transducers apply HIFU energy safely and precisely through the targeted tissue. The UltraCinch device is offered in seven sizes to accommodate varying patient anatomies.

The UltraWand™ Handheld Ablation Device – Using the same transducer technology as in the UltraCinch device, the UltraWand allows complimentary linear lesions to be created during cardiac ablation procedures. This provides physicians with the flexibility to create the lesion set that is most appropriate for each patient.

The Epicor™ Positioning and Sizing (PAS) System – The Epicor PAS System is dual-purpose—designed to indicate the proper UltraCinch device size and act as a guide for simple, accurate placement of that device. It is designed to track smoothly through the cardiac anatomy, and to facilitate less invasive approaches. The tourniquets ensure secure placement of devices on the patient's heart.

Press release: St. Jude Medical Announces CE Mark Approval and FDA Clearance for New Family of HIFU Surgical Ablation Products...

Product page: Epicor™ Cardiac Ablation System...

From a press statement by Terumo:

Earlier generation Left Ventricular Assist devices are prone to hemolysis, blood clots and mechanical failure. Significant advances have been made in the DuraHeart LVAS to potentially overcome these problems. Dr. Nojiri explained: "We have a unique pump design that combines advanced "Mag-Lev" technology and a centrifugal pump. The "Mag-Lev" allows for the complete elimination of mechanical contact within the blood flow path, minimizing the chance of mechanical failure. This is expected to significantly improve the clinical performance and long-term potential of this type of therapy." It has been used in more than 70 patients in Europe with the longest ongoing support over 3 years.

The DuraHeart Bridge-to-Transplant Pivotal Trial is a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The device is intended to provide cardiac support for patients awaiting transplant who are at risk of death due to end-stage left ventricular failure. The National Co-Principal Investigators are Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.

Features from the device page:

* Flow rate from two to eight liters per minute with motor speeds between twelve hundred and twenty-four hundred RPM * Secondary hydrodynamic suspension * Flow rate that varies with physiological changes * Silent pump operation * An advanced Vascutek GelWeave™ outflow graft * Multiple inflow options for optimal fit * Thin flexible percutaneous cable

Press release: August 21, 2008: Discharge of First U.S. DuraHeart(TM) Patient

Press release: August 6, 2008: First DuraHeart™ Left Ventricular Assist System Implanted in the U.S.Pivotal Trial

Device page: DuraHeart System

From the product page:

For the treatment of cardiac arrhythmias, the ATS CryoMaze™ Surgical Ablation System is the only surgical cardiac ablation option that can safely and effectively complete all lesions in the "gold standard" Cox-Maze III procedure with a single product and one energy source. And the versatility of the system makes it adaptable to any procedure or surgical approach.

Cryothermy involves the employment of extremely cold temperatures to ablate specific tissue while leaving underlying connective tissues largely unaffected. This allows the cardiac surgeon to encircle the pulmonary veins with lines of scar tissue to block transmission of erratic electrical signals that trigger atrial fibrillation (atrial fib). The advantage of cryothermy over heat-based therapies is that freezing preserves tissue integrity and minimizes the risk of endocardial thrombus associated with heat-based sources.

Findings from a 1997 study quoted in the product brochure:

All atrial lesions in the study were found to be transmural.

No adverse effect on coronary sinus noted with the ATS CryoMaze probe application for up to 120 seconds.

Under purposeful misapplication directly on the esophagus in in-vivo studies, minimal acute damage was noted in doses up to 90 seconds.

Cryoadhesion offers certainty in lesion placement, minimizing risk of collateral damage.

Press release: ATS Medical Announces CE Mark Regulatory Approval for ATS CryoMaze(TM)

Product page: ATS CryoMaze™ Surgical Ablation System

CryoMaze product brochure (.pdf)...

Here's what the company has just announced:

KLS Martin LP, a medical device company specializing in craniomaxillofacial and sternal fixation, announced today the implantation of the Sternal Talon(R) in the 500th patient.

The Sternal Talon(R) is an alternative method of closure for midline sternotomies used in many heart procedures and utilizes rigid orthopedic-style fixation. Originally developed in conjunction with surgeons at Duke University and surgeons in Tulsa, OK, as a reconstructive alternative for patients with sternal instability and non-unions, the Sternal Talon(R) has been used successfully in primary closure for patients undergoing midline sternotomy for CABG (coronary artery bypass graft) and valvular surgery. Many of these 500 patients had multiple comorbidities, which often lead to significant infections that can be fatal. These patients represent a truly difficult population for sternal closure and until recently the cardiothoracic surgeon had very few treatment options.

"The most common method of sternal closure remains sternal wire, but this is not without problems, especially in the larger patients," says Dr. Arch Miller, one of the inventors from Tulsa, OK. "The patients often exert forces on the wires that can cause the wires to break, pull through the bone or loosen which can lead to sternal instability, infection and increased pain." Using the Sternal Talon(R) on patients with higher BMI (body mass index) improves the chances for better fixation, potentially reducing the risk of sternal complications and resulting in lower patient pain scores allowing them faster recovery.

"One of the most surprising outcomes of the use of the Sternal Talon(R) was the reaction of the post-operative nursing staff who commented that you could tell which patients had the Sternal Talon(R) as they were up and moving around quicker with less pain," said Dr. Miller.

Product page: Rapid Sternal Closure...

Press release...

The following statement was just issued by the company:

The REPLY pacemaker, the world’s smallest dual chamber pacemaker at 8cc’s, is Sorin Group’s next pacing evolution designed to reduce ventricular pacing and promote natural cardiac function.

REPLY integrates Sorin Group’s new proprietary SafeR™ pacing mode. The SafeR technology builds on the Sorin Group's proven AAISafeR™ pacing mode first introduced in Europe in September 2003 and in the US in May 2005. AAISafeR switches from AAI to DDD in case of AV block detection, and has been shown to reduce unnecessary pacing in both Sinus Node Disease and unselected AV Block patients1. Delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation2.

In addition to SafeR, the REPLY pacemaker delivers advanced, automatic features such as SmartCheck™, which lets the user automate follow up tests and provides comprehensive data reporting and recommendations.

“The REPLY pacemaker delivers to the market Sorin Group’s 2nd generation universal pacing platform built around our exclusive SafeR pacing mode. REPLY and SafeR demonstrate Sorin Group’s continued commitment to driving innovation in Cardiac Rhythm Management and reinforces our mission to continuously improve the treatment of Bradycardia”, said Fred Hrkac, President of Sorin Group Cardiac Rhythm Management Business.

Dr. Randy Lieberman, Director of Electrophysiology at Harper University Hospital and Assistant Professor of Medicine at Wayne State University School of Medicine in Detroit implanted the first Reply pacemaker in the US. “The updated 2008 ACC/AHA Guidelines for Device-Based Therapy highlight the new standard of care in pacing which is to minimize unnecessary ventricular pacing. The Reply pacemaker was the right choice for this patient. Pacemaker options that only offer AV delay or AV search hysteresis do not eliminate frequent ventricular pacing for a significant number of patients. It’s important to know that down-sized devices do not mean that physicians have to compromise. Reply provides the output, longevity and pacing algorithms that physicians are looking for in a pacemaker.”

The REPLY pacemaker will be distributed in the United States by ELA Medical, Inc., a Sorin Group Company.

Product page: reply™ dr...

Press release: SORIN GROUP ANNOUNCES FDA APPROVAL AND FIRST U.S. IMPLANT OF THE WORLD'S SMALLEST IMPLANTABLE DUAL CHAMBER PACEMAKER...

According to Virtalis,

The Haption range encompasses a small, desktop device with a translational workspace within a sphere of diameter of 120 mm and rotational workspace of 35O in three directions. Top of the range is the Virtuose 6D35-45, which was designed for the 1:1 scale manipulation of virtual objects and has a massive transational workspace up to a sphere of diameter of 450 mm and can exert forces up to 35 N. All Haption products can be easily integrated into Virtalis StereoWorks installations, so that the Haption device is linked to 3D stereo projection in a fully tracked virtual environment.

Aside from engineering applications, Haption is finding new customers in the kinehaptic field where patients overcome their injuries by practicing their fine motor skills. Surgeons who need to stay within a tightly controlled operating envelope represent another important market for haptics. So do nuclear engineers, whose complex operations when dealing with several robots carrying out specialized dismantling and decommissioning work, have found themselves benefiting greatly from virtual force feedback. In hazardous environments, being able to create the physics of an object, practice manipulating it, optimize the movement path and then record that path, has proved to be invaluable.

If you want to check out the brochure for the Virtuose 6D35-45 device, here it is (.pdf)...

Haption company page...

The video below shows off the technology and demonstrates various cuts using the PlasmaBlade compared to scalpels and bovies.

Peak Surgical homepage...

Press release: PEAK Surgical Receives 510(k) Clearance to Market PEAK® Surgery System for Use in General Surgery...

Flashback: Peak PlasmaBlade Wants to Be The New Bovie

The Zenith TX2 TAA Endovascular Graft with the H&L-B One-Shot Introduction System is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including:

Adequate iliac/femoral access compatible with the required introduction systems,

Non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm or ulcer:

with a length of at least 25 mm, and

with a diameter measured outer wall to outer wall of no more than 38 mm and no less than 24 mm

Product page: Zenith TX2® TAA...

Press release: Cook Medical Announces the First Commercial Placement of the Zenith TX2® TAA Endovascular Graft in the United States...

Flashback: Zenith TX2 Thoracic TAA Endovascular Graft

From the press release:

The sensor is constructed from silicon and vibrates at a rate which varies according to the pressure inside the heart. Once at home, patients would wear a reader, a miniature device that detects these vibrations through radio pulses, and translates them into precise measurements.

Patients would be able view their own readings at home via the reader, while doctors could take measurements by dialling up the reader via a mobile phone or by logging onto a secure internet site. The reader could also be set to automatically send alarms to the doctor if a patient’s heart reading reaches critical levels.

Lead researcher, Professor Christofer Toumazou, from Imperial College London’s Institute of Biomedical Engineering, says:

“The heart pressure sensor could transform the lives of people living with chronic heart problems and has the potential to revolutionise heart monitoring. At the touch of a few buttons a family doctor could dial up their patient’s heart history and plot pressure trends to better manage their condition and prevent the progression of heart failure.”

Sir Magdi Yacoub, Professor of Cardiothoracic Surgery at Imperial College London, has trialled the pressure sensor successfully on animal laboratory models.

Press release: Implantable sensor will revolutionise the management of heart disease, say Imperial researchers ...