The Medical Device Manufacturers Association (MDMA; Washington) will hold its 9th annual Coverage, Reimbursement and Health Policy Conference in Washington Nov. 8-9, at the Madison Hotel.

The two-day program is designed to educate and inform participants about increasingly complex and important reimbursement issues. Attendees will learn the latest information on the coverage, coding, and payment of medical technologies.

Understanding the various steps in the reimbursement process is critical to the success of medical technology companies. The conference will focus on developing strategies that result in “timely, adequate and appropriate” reimbursement, MDMA said.

For information, visit. www.medicaldevices.org.

Eclipsys meets CCHIT criteria for 2006

Eclipsys (Boca Raton, Florida) reported it meets Certification Commission for Healthcare Information Technology’s ambulatory Electronic Health Record criteria for 2006.

CCHIT is the recognized authority in the United States for certifying EHR products.

As a CCHIT-certified product, Eclipsys said Sunrise Ambulatory Care has been tested and passed inspection of 100 percent of a comprehensive set of criteria for functionality, interoperability, and security.

Eclipsys provides advanced integrated information software, clinical content and professional services.

Sontra Medical not in Nasdaq compliance

Sontra Medical (Franklin, Massachusetts) said it received a deficiency letter Oct. 17 from the Nasdaq Stock Market indicating it is not in compliance with the continued listing requirements of The Nasdaq Capital Market because for the previous 30 consecutive business days, the bid price had closed below the $1 minimum per share requirement for continued listing. By Nasdaq rule, Sontra will be allowed 180 calendar days to regain compliance with the minimum bid price rule. The letter from Nasdaq has no effect on the listing of Sontra Medical’s common stock.

Sontra has 180 calendar days to regain compliance by having the bid price of its common stock close at $1 per share or more for at least 10 consecutive business days. If it does not regain compliance by April 16 Sontra will be issued a delisting letter.

Sontra Medical develops a non-invasive, continuous transdermal glucose monitor for principal use in the Intensive Care market and Sontra makes products for transdermal delivery of large molecule drugs and vaccines.

New Brunswick not in Nasdaq compliance

New Brunswick Scientific (Edison, New Jersey), a provider of a line of research equipment and scientific instrumentation for use in the life science industry, said it has received a notification from the Nasdaq Listing Qualifications Department that, as a result of the untimely death of one of its directors, Joel Jaffe on October 8, 2006, it was no longer in compliance with Nasdaq’s audit committee requirements because it currently had only two independent directors serving on its audit committee.

SRS relocates HQ

SRS Medical (Redmond, Washington) reported it has moved its West Coast operations to a larger facility in Redmond and plans to expand its East Coast operations later this quarter.

Kevin Connolly, CEO, said new facilities were needed to serve the company’s expanding customer base. “We recently completed the acquisitions and development that were required to assemble the industry’s most comprehensive and innovative product suite for continence care. Our new Redmond facility immediately doubles our warehouse space for supplies and allows us to further increase capacity in the near future. Our new East Coast facility will house expanded customer support and engineering groups.”

SRS Medical acquires technologies in the areas of incontinence and women’s health. In January it acquired all assets related to devices for the treatment of severe female incontinence from Eutech Medical (Gothenburg, Sweden). In October 2003, it acquired all assets related to urodynamic products and certain incontinence treatment devices from Endocare (Irvine, California) and before that acquired the assets of Asbrook/Eris (Ventura, California), a manufacturer of urodynamic products, as well as the In-Flow female catheter from American Medical Systems (Minnetonka Minnesota).

SRS said its telephone numbers and hours of operation remain the same.

Complex tasks easier with brain exercise in seniors

A carefully designed brain exercise regimen can significantly improve the ability of older adults to perform complex tasks, according to researchers from Posit Science (San Francisco), who presented a study this month at the Society for Neuroscience (Washington) a gathering of 30,000 brain scientists in Atlanta.

“Complex tasks place demands on attention and working memory,” said Natasha Belfor, PhD, an author of the study. “We know that attention and working memory decline with age, which is why fairly routine tasks can seem increasingly challenging as we age.”

The meta-analysis of several randomized, controlled studies showed that participants who engaged in an eight-week brain exercise regimen showed statistically significant improvement in a cognitive test designed to measure performance at complex tasks. The standardized test is commonly known as the Token Task, and it measures a person’s ability to follow increasingly complex instructions.

First patient treated in CryoCath’s IDE STOP AF trial

CryoCath Technologies (Montreal) reported the first patient has been enrolled and treated in its pivotal Investigational Device (IDE) STOP AF trial. The FDA-approved trial is designed to demonstrate Arctic Front’s clinical and therapeutic effectiveness in treating Atrial Fibrillation (AF).

The patient was enrolled by Kevin Wheelan, MD, and treated at the Baylor Medical Center (Dallas). The procedure was considered an acute success. There were no safety concerns noted, including no reports of phrenic nerve injury, thrombosis, or stroke.

“We consider the enrollment and successful treatment of the first patient an important step forward,” said Jean-Pierre Desmarais, CryoCath’s chief scientific officer. “We anticipate that the other centers participating in the trial will begin recruiting patients shortly and that the trial will continue to steadily proceed.”

As many as 250 patients, randomized into two arms, will be enrolled to complete the trial. One cohort will receive cryoablation therapy with Arctic Front (the ablation arm); the other will receive currently prescribed drug therapies (the control arm). For every two patients in the ablation arm, there will be one in the control arm. Patients in the trial will be highly symptomatic paroxysmal AF patients who have failed at least one anti-arrhythmic drug. The trial’s primary endpoint will be the absence of detectable AF at the end of the 12-month follow up period. The trial’s design also allows patients randomized into the drug arm to cross over into the ablation arm if they do not show improvement.

Arctic Front is a minimally invasive cryo-balloon catheter designed specifically to treat Atrial Fibrillation. The bi-directional, double balloon catheter enables physicians to rapidly isolate all four pulmonary veins for the treatment of AF. Approved in Europe, it has treated more than 250 patients in more than 15 centers.

AF, described as a rapid and chaotic quivering of the top two chambers in the heart, is the most prevalent arrhythmia, affecting more than 2 million patients in the U.S. with 160,000 new cases per year. It is a leading cause of stroke and hospitalizations, and has become the most common complication of cardiovascular surgery. If left untreated, it can lead to heart failure and death.

CryoCath makes cryotherapy products to treat cardiovascular disease.

First commercial installation of Innova IVUS completed

GE Healthcare (Waukesha, Wisconsin) and Volcano (Rancho Cordova, California) reported the first commercial installation of Innova IVUS at PinnacleHealth Heart and Vascular Institute at Harrisburg Hospital (Harrisburg, Pennsylvania) is complete.

Innova IVUS is GE Healthcare’s custom integration of Volcano’s s5i IVUS imaging system with the Innova all-digital X-ray cath lab imaging system. Innova IVUS optimizes clinical workflow by offering IVUS controls on the Innova Central bedside touchscreen. Data exchange between the IVUS system and Innova allows for automatic patient data transfer from Innova for IVUS cases and advanced archiving that links IVUS cases to cath cases.

Volcano’s s5i product uses a new PC-based platform that reduces the size, weight and noise of the older generation IVUS consoles. This allows the unit to be located in the control room or in other areas outside of the daily traffic pattern of the cath lab. Clinicians have the ability to control the IVUS system through a variety of control devices located at the patient bedside, at the point of care, or both. Clinicians also have the flexibility to view IVUS images on the existing monitor bank, a separate dedicated IVUS monitor, and/or on a monitor in the control room.

GE and Volcano also reported GE’s plans to include the cabling required to operate Volcano’s IVUS technology on all future U.S. installations of GE Healthcare’s Innova imaging systems. The inclusion of IVUS cabling as part of the standard installation creates the infrastructure required to operate Innova IVUS.

GE Healthcare provides transformational medical technologies and offers a broad range of products and services intended to improve productivity in healthcare and enhance patient care.

Volcano offers a broad suite of devices used during endovascular procedures.

CryoLife to host cardiac reconstruction symposium

CryoLife (Kennesaw, Georgia) a biomaterials and biosurgical device company, hosted a cardiac reconstruction symposium focusing on the use of human heart valves and tissues at its headquarters training facility in Kennesaw, Georgia this past weekend. The program included: current indications and clinical outcomes, surgical techniques associated with the implantation of aortic and pulmonary allografts, and advances in tissue engineering related to cardiac reconstruction.

CryoLife distributes implantable living human tissues for use in cardiovascular, vascular, and orthopedic surgeries throughout the United States and Canada.

Biopure not in Nasdaq compliance

Biopure (Cambridge, Massachusetts) said it received notice from Nasdaq that its closing bid price fell and remained below $1 for 30 consecutive business days. As a result, Biopure is out of compliance with Nasdaq’s $1 minimum bid price requirement for continued. The notification has no effect on the listing of the company’s common stock. Biopure has 180 calendar days to regain compliance by having the bid price of its common stock close at $1 per share or more for at least 10 consecutive business days. If it does not regain compliance by April 16 it may apply to transfer its securities to The Nasdaq Capital Market and take advantage of the additional 180-day compliance period offered on that market, if it satisfies the requirements for initial listing on that market except for the bid price requirement. If Biopure does not demonstrate compliance within the compliance period, it will be issued a delisting letter.

Biopure makes pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body’s tissues.

BSD Medical launches new web site

BSD Medical (Salt Lake City) said it has launched an interactive web site providing information and resources to physicians about BSD Medical’s cancer therapy, www.heatcancer.com.

That is the third stage of an Internet campaign directed at educating patients, and now physicians, on therapies available through BSD’s cancer treatment.

Kika Medical selected for EDC

Kika Medical (Boston) a provider of advanced web-based solutions for clinical studies, reported that it has been selected to provide electronic data capture (EDC) services for one of the largest drug-eluting stent post-marketing registries in the cardiovascular field. Run by one of the leader of interventional medicine products, this registry will involve over 30,000 patients in 500 centers in more than 40 countries.