Transoma Medical Receives FDA Marketing Clearance For Exclusive Capability Providing Immediate Access To Critical ECGs On Mobile Handheld Device

Transoma Medical, Inc., manufacturer of Sleuth® and Sleuth AT™, the only wireless and automated implantable cardiac monitoring (ICM) systems has received FDA 510(k) marketing clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient's Personal Diagnostic Manager (PDM). The PDM is a handheld device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event making it easier for clinicians to correlate symptoms with rhythms.

"Instant access to a patient's ECG data on the mobile handheld device is a clinically valuable tool in urgent situations, such as when the patient presents in the emergency room," said Dr. Asim Yunus, an electrophysiologist with Michigan Cardiovascular Institute in Saginaw, Mich. "Transoma continues to advance cardiac monitoring technology with their devices. The Sleuth systems already provided information much faster and more efficiently than other implantable monitoring options. Now, with Data Review, we don't even have to wait for the automatic downloads to the monitoring center because the events are right there on the handheld device. This kind of access to information has never been available before."

As a complete, remote and automated system, Sleuth AT offers several advantages over other available implantable monitoring products. The system includes a small implanted device that incorporates the most sensitive arrhythmia detector of any ICM on the market. Not only does Sleuth AT capture ECG strips containing arrhythmias automatically, it also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center where certified cardiac technicians review the data and alert clinicians to clinically-significant events, providing a high degree of specificity. And now, with Data Review, ECG recordings that have not yet been transmitted to the monitoring center can be accessed directly on the handheld PDM.

"As a device clinic coordinator, it is not uncommon for me to manage data on 2,000 or more patients at a given time from a variety of cardiac monitoring systems," said Lori Fravel, BSN, CCRN, CCDS, a nurse who supports 10 cardiologists at Mt. Carmel Columbus Cardiology Consultants in Columbus, Ohio. "I have found the Sleuth systems to be extremely efficient because I am only alerted to clinically-significant events and I never have to call the patient to coordinate manual interrogation of his or her device. The setup of the system allows me to get the information I need in a much more streamlined fashion. Now with Sleuth AT, the added benefit of ECG access on the handheld device means any available clinician can view recently captured events without a programmer, even if the patient has been away from home. I am hopeful this will further speed access to critical information."

"With the addition of the Data Review feature, the Sleuth AT system is designed to be an even better and more accurate diagnostic tool that further enhances efficiency for the practice and simplicity for the patient," said Nestor Jaramillo, Transoma Medical vice president of sales and marketing. "Our goal is to assure that clinicians have access to the right cardiac information at the right time in the simplest and most efficient manner possible. Providing the right information to the physician can lead to faster diagnosis and selection of the right therapeutic regimen for the patient. Everyone can benefit. At Transoma Medical, we believe better treatment starts with better information."

The Sleuth AT System

* The Implantable Cardiac Monitor is a small, thin device, about the size of a 50-cent piece (or the size of the smallest pacemakers), which continuously monitors the electrical activity of the heart, the ECG. The cardiac monitor is implanted under the skin during a brief, simple, outpatient procedure.
* The Personal Diagnostic Manager (PDM) is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the implanted cardiac monitor and securely relays the information through a base station to the monitoring center. The PDM is also used by the physician to program the implanted cardiac monitor and even to view non-transmitted ECGs immediately after capture. Data are collected in three ways:
o Patients who experience symptoms, such as lightheadedness, can press a button on the PDM which tells the system to store the patient's ECG strip during the time of the symptom.
o The system automatically captures and stores the ECG strip when the patient's heart rate is above or below physician-programmed limits.
o The system can be programmed to capture regular ECG strips every four hours, 15 minutes or 7.5 minutes.
* At the third-party Monitoring Center, certified cardiac technicians review the patient's ECG data and provide information to the physician to aid in diagnosis and ongoing treatment. Physicians can access this information via a secure Web portal, and have the reports faxed or e-mailed to them as they prefer. If the cardiac technician observes a particularly concerning arrhythmia, the patient's physician will be contacted immediately.

Source: Medical Design Online

FDA Approves SBi's S.T.A.R. Total Ankle Replacement System

Small Bone Innovations, Inc. (SBi), a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced today that the U.S. Food and Drug Administration (FDA) has approved SBi's Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients. S.T.A.R. has received pre-market approval (PMA) to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.

S.T.A.R. has more than 19 years of clinical experience and the current design has been implanted in over 15,200 patients worldwide. Additionally, there have been 35 peer-reviewed clinical outcomes papers published on S.T.A.R.; SBi believes that this number of papers is more than any other mobile-bearing total ankle arthroplasty device.

A U.S. Investigational Device Exemption (IDE) Clinical Trial of S.T.A.R. was initiated in August, 2000 as a prospective, multi-center controlled pivotal study to compare the safety and efficacy of S.T.A.R. to ankle fusion (the current standard of care). The study, which followed patients for a minimum of 24 months, is the only U.S. IDE clinical trial to have been completed on a three-piece, mobile-bearing, non-constrained, uncemented total ankle replacement system.

More than 670 patients were enrolled in the pivotal and continued access phases of the IDE clinical trial. The lead investigators were Roger A. Mann, MD, of Oakland Bone & Joint Specialists, Oakland, CA and consulting surgeon at the Steadman-Hawkins Clinic, Vail, CO and Michael J. Coughlin, MD, of the Idaho Orthopaedic Institute at St. Alphonsus Regional Medical Center, Boise, ID.

Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The ‘Instructions for Use' and ‘Patient Labeling' issued by the FDA indicate that ‘S.T.A.R. patients had superior effectiveness compared to ankle fusion and had comparable safety results compared to ankle fusion in the clinical trials. No other total ankle replacement system can make this claim."

Additionally, Mr. Viscogliosi continued, "S.T.A.R. was less invasive than fusion, with less blood loss, shorter operating time, and better pain relief. We are now able to provide surgeons and their patients with a proven, advanced technology that we believe will change the standard of care from fusion to total ankle arthroplasty."

Currently, there are a few 510(k) ankle replacement devices cleared for U.S. marketing as an alternative to fusion. All of these ankle replacements are fixed-bearing devices that limit motion and are indicated for use with bone cement.

"S.T.A.R. is the only FDA-approved total ankle replacement system for uncemented use, which allows for better bone in-growth, stabilization and bone preservation," Mr. Viscogliosi concluded.

Thomas A. Crowley, President of SBi, said: "We expect high patient demand for the S.T.A.R. total ankle replacement system and we will strategically manage that demand through a controlled introduction and surgeon training, supported by continued long term follow-up of patients for eight years."

Roger A. Mann, MD said: "There is already widespread awareness and interest in the S.T.A.R. ankle replacement among U.S. foot and ankle surgeons. For those of us who participated in the clinical trial and have observed the successful clinical outcomes among our patients, this may well be an important moment in orthopedics, similar to those we've seen in hip, knee and spine, when the gold standard transitioned from fusion to arthroplasty."

Surgeons mentioned in this release provide consulting services to SBi.

Source: Medical Design Online