BB&T Staff Writer and BB&T Staff Reports

While there haven t been any firm estimates on the off-label use of devices treating atrial fibrillation (AF), the fact remains that this is a strong concern for the FDA especially since in the past there haven t been any devices specifically approved for this indication. That s changed recently, as AtriCure (West Chester, Ohio) reported that it has gained FDA approval for its Synergy ablation system for the treatment of AF.

Specifically the company has been given the nod to have the device treat patients with persistent and long-standing persistent AF during open-heart concomitant coronary artery bypass grafting and/or valve replacement or repair procedures.

The device is approved for AF, and we estimate in the United States that there are roughly 80,000 patients that are undergoing a bypass and or valve procedure that have AF. Only about 20,000 of those patients today are treated, Julie Piton, VP finance and administration and CFO of AtriCure told BB&T.

The company is making the claim that this is the first time a surgical ablation system has been approved for the treatment of AF and the first time any system, catheter or surgical, has been approved in the U.S. for the treatment of patients with persistent and long-standing persistent AF.

Following approval, the firm has been asked by the FDA to implement a post approval study and offer a physician training program.

The Synergy ablation system includes AtriCure s Isolator Synergy clamps, a radio frequency generator and related switchbox. It was previously cleared in the U.S. for cardiac tissue ablation during concomitant open-heart surgical procedures. The device has the CE mark.

The post approval study is a 350-patient study with a three-year follow-up and the patients will be tracked annually, Piton said. Additionally we ve already enrolled about 46 of those patients through the ABLATE AF trial. In terms of training, since the product is already commercially available [under cardiac tissue ablation] what we will do for our new customers is have a training program for them.

Back in October the firm won a 5-4 final vote from an FDA advisory panel. The panel concluded that the device is effective, but that safety may present lingering questions. The panel voted unanimously 9-0 that the device was effective.

Piton declined to go into specifics about the FDA panel s October vote, but said the trial met the safety endpoints which I think is the important point, with adverse events at 9.9%, so I think this is the most critical piece the company would respond to, that we met our endpoints with respect to safety and efficacy for the trial that was designed.

Synergy s approval helps put the company in a more attractive spot. For months, analysts praised the company calling it an attractive M&A target. In October Canaccord (Toronto) biomedical devices analyst Jason Mills wrote in a quarterly report that AtriCure is a leading A-Fib franchise with new products.

We like the company s leadership position in the surgical atrial fibrillation market currently, and we also favor the company s new product and clinical trial pipeline, Mills wrote. Both make us optimistic the company can produce double-digit growth for awhile.

While Piton would not comment on the specifics of Mills report, she did add that the company believed itself to be a leader in this space.

We believe we have the most market share in the U.S. with respect to surgical ablation for the treatment of AF, she said. We believe our market share is 50% or more.

The company now has a significant advantage over other med-tech firms in the space said Larry Haimovitch, president of Haimovitch Medical Technology Consultants (Mill Valley, California) and a regular contributor to BB&T.

I think this puts AtriCure at the very head of the class, Haimovitch told BB&T. They have been the first to pursue a PMA [for this indication].

Haimovitch added that this approval now puts the company clearly in a leadership position, and any big company it could be Johnson & Johnson [New Brunswick, New Jersey], it could be St. Jude Medical [St. Paul, Minnesota], it could be one of several large med-tech companies that could certainly find this company more attractive now.

He noted that the company has garnered a significant amount of success throughout the past few years.

In June 2010, AtriCure became the first company to receive FDA approval for any LAA occluder. Its AtriClip device is implanted in an open chest procedure and has quickly established itself as an important new product in the cardiothoracic surgery world.

This marks the achievement of a major milestone for AtriCure, the field of cardiac surgery, and the treatment of AF. The approval confirms the effectiveness of the Synergy ablation system and recognizes the increasing need for the surgical treatment of AF, said David Drachman, president/CEO. We look forward to educating physicians and patients on our surgical alternative for the treatment of AF, which we believe will raise awareness for a large number of AF patients that are currently being undertreated.

Elsewhere in the product pipeline:

Abbott (Abbott Park, Illinois) has received FDA clearance for a fully-automated 25-OH Vitamin D assay performed on its Architect laboratory testing platform. With a simple blood test, the Architect 25-OH Vitamin D assay can measure the stable form of vitamin D, 25-hydroxyvitamin D (25-OH vitamin D), the body s repository of vitamin D. In the kidneys, 25-OH vitamin D converts into the active form of the vitamin that helps regulate calcium and phosphate levels. 25-OH vitamin D is established as the appropriate measurable indicator of vitamin D status because it is stable and easily measured. Low vitamin D can cause skeletal disorders, such as rickets in children and bone loss in adults, and has been linked to an increased risk of hip fractures. Although research is still being conducted in this area, some studies have shown that people with a low level of vitamin D may have elevated risk for cardiovascular problems, autoimmune disorders and some infectious diseases.

Agendia (Irvine, California) reported the introduction of formalin fixed, paraffin embedded tissue technology applied to their Symphony suite of breast cancer assays. Agendia s breast cancer Symphony suite of products leverage the predictive and prognostic power of four separate and distinct assays to provide a comprehensive decision support system. Symphony assists physicians in determining which patients will benefit from chemo therapy, hormonal therapy, or combination therapies, preventing unnecessary suffering from short and long term side effects and burdensome costs to the overall health care system. Symphony includes MammaPrint, which determines the risk of recurrence; BluePrint determines molecular subtypes; TargetPrint determines ER, PR and HER2 status; and TheraPrint identifies alternative types of therapy for metastatic disease.

Ascom Wireless Solutions (Gothenburg, Sweden) said they have received Medical Device Directive clearance by the Swedish Medical Products Agency for their Mobile Monitoring Gateway (MMG). The MMG is a component in the GE Ascom Solution. Jointly developed by GE Healthcare and Ascom, the GE Ascom Solution is a wireless hospital-wide messaging system designed to improve workflow and communication for healthcare providers. The MMG provides an interface between GE Healthcare Carescape Network and Ascom Unite Professional Messaging and Alarm Application. It enables hospitals to customize, filter and send secondary alarms to inform healthcare professionals of particular medical related events captured by the GE Healthcare Carescape Network. The alarm is forwarded to Ascom handsets or a wide variety of devices, including pagers, mobile handsets and/or LED signs.

Bluegrass Vascular Technologies (Lexington, Kentucky) reported patient enrollment in the first clinical study of its Surfacer Inside-Out access catheter system, a system designed to allow physicians to perform an inside-out approach to gain venous access. The prospective single-center feasibility study will evaluate the safety and effectiveness of the Surfacer in up to 10 patients with upper extremity venous occlusion (or blockage in the vein). Conducted by principal investigator Adrian Ebner, MD, at the Sanitorio Italiano in Asunci n (Paraguay), the study commenced with the successful treatment of six patients in early December.

CareFusion (San Diego) launched the Pyxis Enterprise System platform, a new generation of its automated dispensing systems that will enable hospital customers to simplify and standardize the medication management process, both within a single facility and across an entire health system. With the Pyxis Enterprise Server, hospitals now only need to manage one dispensing system for the entire hospital or health network. This improvement allows pharmacies to manage just one formulary in the Pharmacy Information System and cascade the data to the Pyxis Enterprise Server, permitting the PIS to serve as the single source for the formulary, the company said. The device hardware features introduce a new standard in dispensing cabinet system supportability and reliability.

DePuy Spine (Raynham, Massachusetts) reported the launch of the Expedium Neuromuscular System, a new modular system of pre-contoured rods and proximal connectors, open and closed iliac screw designs and wires, designed to help surgeons address spinal and pelvic deformity in patients with neuromuscular scoliosis. The modularity of the Expedium Neuromuscular System allows for easy fixation to the pelvis without the need for intra-operative modification of implants or complex rod bending. It also allows for the cantilever correction of severe pelvic obliquity and spinal deformity that was previously corrected with the unit rod, said Kirk Dabney, MD, orthopedic surgeon and associate director of the Cerebral Palsy Program at the Alfred I. duPont Institute in Wilmington, Delaware.

Echo Therapeutics (Philadelphia), the maker of the Symphony tCGM System a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude SkinPrep System for transdermal drug delivery, reported positive results from its clinical study of its Symphony tCGM System in patients with Type 1 and Type 2 diabetes. Data from the study confirm that Symphony monitors the broad range of blood glucose values seen in people with diabetes. Echo also reported that it plans to conduct a study in critical care patients in the near term.

Exactech (Gainesville, Florida) reported the full market launch of its Gibralt spinal system. The Gibralt spinal system is a comprehensive solution for posterior stabilization and an adjunct to fusion of the cervical and upper thoracic spine. Gibralt features top loading polyaxial screws, hooks, offset connectors, and rod-to-rod connectors which can be constructed into a multitude of configurations based individual patient anatomy. The low-profile pedicle screw with 80 degrees of motion is designed to reduce the risk of tissue impingement in the thoracic spine, and the EZ Set tulip head allows the tulip head to be easily positioned and set for rod insertion. The Tightlok thread technology of the thread provides high biomechanical strength, resisting screw pullout.

Iridex (Mountain View, California) said that data from a clinical study compiled over 10 years demonstrates the safety and efficacy of MicroPulse laser therapy for treating diabetic macular edema without the retina tissue damage associated with conventional laser therapy. MicroPulse is a tissue-sparing laser therapy that works by electronically chopping the laser emission into trains of microsecond pulses. This enhances the physician s ability to more precisely control the laser effects on target tissues, offering the potential for ocular treatment with less collateral effects than conventional laser treatments.

Molex (Lisle, Illinois) reported the offering of a selected series of core micro products, which will be available for purchase, replacement and technical support for up to ten years, in order to more accurately align with medical industry design cycles. Micro interconnect solutions, including Molex FFC/FPC, board-to-board, microminiature wire-to-board and memory card connectors, are used in a wide range of medical device applications. Molex micro products align with the trend toward smaller, lighter and integrated solutions for mobile and portable medical applications. The offerings include: the SlimStack 0.40 mm pitch, board-to-board system which provides approximately a 25% overall space savings compared to competitive styles; the IllumiMate 2.00 mm wire-to-board system which supplies the narrowest width of any similar low-power connector systems, along with significant cost and performance advantages; and the FPC 0.30 mm pitch dual-contact connector which offers the shortest length and most secure FPC retention compared with similar competitive versions.

NovaSom (Glen Burnie, Maryland), a maker of obstructive sleep apnea (OSA) home testing and cost-containment solutions, reported the launch of its next-generation MediTrack cloud-based CRM application. The MediTrack OSA management platform is designed to enable custom processing of payer-specific medical policy, billing, utilization management and therapy coordination requirements to efficiently manage home sleep testing, OSA diagnosis and recommended therapy. NovaSom s MediTrack system allows physicians to order a NovaSom home sleep test online or by fax. The platform provides customizable information fields for easier physician entry of payer required data, leverages payer communication preferences, and incorporates payer-specific messaging into patient shipping and handling and device return logistics.

OraSure Technologies (Bethlehem, Pennsylvania) subsidiary, DNA Genotek (Ottawa), a provider of products for biological sample collection, stabilization and preparation, reported FDA clearance for DNA Genotek s Oragene-Dx collection device. Oragene-Dx is a saliva DNA collection and stabilization device. DNA Genotek s lead product line, Oragene, provides a system for the collection, stabilization, and transportation of DNA from saliva. Oragene provides reliable collection of high quality DNA samples using a simple, non-invasive method and the ability to transport and store collected samples for extended periods at ambient temperatures. Oragene-Dx is suitable for use in FDA-cleared molecular diagnostic applications and was cleared using results from the eSensor Warfarin Sensitivity Saliva Test.

Panasonic Healthcare Group (Secaucus, New Jersey) reported the launch of the Panasonic JZ Power WH-105JZ hearing instrument with binaural audio headset. The JZ Power WH-105JZ, designed for mild to severe hearing loss, using technology to expand on hearing range as compared with previous generation models. A palm-sized unit featuring an LCD screen and a stereo binaural headset (earphone with microphones) which is designed to comfortably fit into the ear canal and stay in place for long hours of wear, the new JZ Power provides ease-of-use in a simple, user-friendly design.

St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its Unify Quadra cardiac resynchronization therapy defibrillator (CRT-D) and Quartet Left Ventricular Quadripolar Pacing Lead. This is the industry s first quadripolar pacing system, which St. Jude says allows cardiologists to better manage CRT. Defibrillators are implanted in the chest and usually connected to the heart with leads, synchronizing the heart s lower chambers which are often out of sync in heart failure patients so they are more efficient in pumping blood to the body. The Quadra and Quartet use a pacing lead with four electrodes, which enables more pacing configurations and reduces common problems associated with implantable CRT systems, and ultimately results in fewer surgeries for patients.

Toshiba America Medical Systems (Tustin, California) has added two new enhancements to the Radrex-i digital radiographic (DR) X-ray system DICOM radiation dose structured reporting and reject analysis software. Toshiba s DICOM automatically records radiation dose information for every X-ray exam, making it easier for hospitals to document, manage and evaluate overall dose usage. The report is in compliance with the Integrating the Healthcare Enterprise Radiation Exposure Monitoring (IHE REM) profile. The Radrex-i system places users at the forefront of patient safety because the level and detail of dose reporting exceed what is required today from leading medical imaging organizations.

X-spine (Miamisburg, Ohio) reported FDA clearance of the Axle-PEEK interspinous fusion system. The Axle-PEEK system consists of spinal implants FDA-cleared for the treatment of degenerative disk disease (DDD). The system expands on X-spine s Axle line of interspinous fusion devices by incorporating an insert manufactured from PEEK-Optima provided by Invibio Biomaterial Solutions. The Axle-PEEK implants can be placed through a smaller incision and with less disruption of tissues than traditional spinal fusion devices. With this clearance, X-spine uniquely offers spine surgeons a choice of implant materials, either titanium or polymer, in a single device. X-spine makes implants and instrumentation for surgery of the spine. Invibio makes biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets.