To treat atrial fibrillation (AF), the main therapy is often medication. However, in about 60% of patients with AF, medication does not stop the symptoms, primarily an uncontrollable rapid heartbeat that can produce various co-morbidities and result in a serious decline in health. This problem is driving companies to seek a variety of treatments, most, to date, being fairly invasive.

Among the several companies seeking a less-invasive treatment for AF is ProRhythm (Ronkonkoma, New York), Richard Fischer, company CFO, told Cardiovascular Device Update. The company reported that the first patient in its first pivotal trial recently was treated using its High Intensity Focused Ultrasound (HIFU) Ablation System, meaning that the energy produced and used is focused in a small area.

The initial procedure — which the company characterized as a critical milestone for it — was performed at Beaumont Hospital (Royal Oak, Michigan). “Ablations for AF are done on an off-label basis by very experienced electrophysiologists today by using a standard RF [radio frequency] catheter and trying to do point-by-point ablations around vein osteums, so they try to connect the dots of the [pulmonary vein],” Fischer said.

ProRhythm’s product involves the use of a balloon catheter, used to apply a “relatively short burst of [ultrasound] energy, between 40 and 60 seconds,” to create a lesion that “blocks the extraneous electrical signals” that ultimately are thought to cause AF. The company compares this to the focusing of sunlight to create an intense spot of heat as a method of ablation, targeting a site that avoids damage to surrounding tissue.

The AF ablation procedure is one of what are commonly called Pulmonary Vein Isolation (PVI), the company said, although none of these treatments have been approved by the FDA. Rather, like some drugs, they are used in an “off-label” basis.

During this first procedure in the pivotal trial at Beaumont Hospital, performed by Dr. David Haines, the physician was able to position the HIFU Ablation Catheter at each of the four pulmonary veins and successfully block electrical conduction from each of the pulmonary veins to the left of the heart.

“The system was able to deliver energy to the intended locations in a highly efficient and effective manner,” said Haines, director of the Heart Rhythm Center at Beaumont. “We are hopeful that the HIFU procedure will allow the patients to lead a life that is free of atrial fibrillation.”

Fischer told CDU that the study — in which ProRhythm intends to enroll about 100 patients — will likely take a year to complete, depending on the time required for full enrollment. At that point, the FDA is requiring 12-month follow-up on all patients, at best taking the company through the end of 2008 for approval.

“The initiation of the pivotal study is a critical step along the path toward commercialization of our HIFU technology in the U.S.,” said Reinhard Warnking, president/CEO of ProRhythm. “The acute results of the first procedure mirror the results seen in the feasibility phase of the trial.”

Electrophysiologist Dan Dan, MD, who practices at Piedmont Hospital (Atlanta), is participating in the ProRhythm clinical trial. The problem of AF is only going to increase with the aging population, he said, because it is a condition that is “more prevalent with advancing age.” The good news in that scenario is that people are more aware of AF and recognize its symptoms than they were 10 years ago, he said. Dan said he wanted to participate in ProRhythm’s trial because he was “very interested” in its technology, describing it as “relatively straightforward.”

It’s a very powerful technology and makes very good lesions, [that is] lesions that can be controlled . . . [which] is very important to long-term success,” he said. “And also the use of the balloon actually facilitates good lesions in the left atrium that isolates the pulmonary veins, which are the major culprits for this disease.”

Formerly named TransSurgical, the company adopted the name ProRhythm in 2004. Fischer said that originally the company had more than one focus, as suggested by the name TransSurgical, and had pursued the thought that by administering focused ultrasound extracorporeally on a tumor site, it could produce a viable treatment not requiring incisional surgery.

Fischer said that when Warnking joined the company in 2001, he shifted the focus to HIFU for AF, having decided that was the “best opportunity” for commercial success.

The company said that globally, more than 6 million people are affected by AF but that drugs and other available treatments are very expensive and frequently don’t help the problem. “That’s why a lot of the emerging medical device companies are trying to find the so-called ‘Holy Grail’ of a minimally-invasive device that could [provide] hopefully a permanent cure for it and avoid the use of drugs and all the side effects,” Fischer told MDD.

Elsewhere in the product pipeline:

Abiomed (Danvers, Massachusetts) reported FDA clearance of its new intra-aortic balloon (IAB), billing it as an “easy-to-insert,” minimally invasive technology enhancing blood flow to the heart and other organs for patients with diminished heart function. It said the balloon, in reliability testing, demonstrated a life of more than eight million cycles, equating to more than 90 days of continuous operation. The company also has developed a combination console platform, the iPulse, currently under regulatory review, to support the IAB. The new iPulse console will also support Abiomed’s BVS and AB5000 circulatory support systems, as well as future product introductions by Abiomed. The company said this new IAB technology strengthens its portfolio of products, which now includes three platforms (Impella, iPulse, and AbioCor) and consists of seven disposable devices that span the cath lab to the intensive care unit to the surgery suite. Abiomed’s 8 French IAB is inserted percutaneously into a patient’s descending aorta and inflates and deflates in counterpulsation to a patient’s heart rhythm. The new iPulse console will support procedures with associated Medicare reimbursement that extends across four diagnostic related groups, ranging from $15,000 to $180,000 per patient stay. The return on investment for the iPulse console can be achieved in less than six months, the company says. Mike Minogue, president/CEO, said Abiomed “plans to enter this $200 million additional market consisting of 160,000 patients with a combination of our IAB, Impella and AB5000 technologies to achieve the best recovery outcomes.”

Atrium Medical (Hudson, New Hampshire) reported receiving FDA 510(k) clearance for its new small vessel therapeutic perfusion catheter, ClearWay RX, indicated for localized delivery of therapeutic agents to the coronary and peripheral vasculature. Atrium says ClearWay RX is the world’s first Rapid Exchange therapeutic perfusion catheter for localized therapeutic delivery within small-caliber vessels. ClearWay RX is a low-pressure perfusion catheter incorporating a thin, semi-compliant microporous PTFE balloon material to deliver small quantities of medication, allowing for controlled infusion at very low pressures (2 - 4 atm) for maximum local therapeutic effect at a discrete targeted location. The rapid exchange perfusion catheter is .014” guidewire compatible, allowing access to several difficult-to-reach destinations throughout the body. Atrium develops technologies for the treatment of heart and vascular disease.

CPC of America (Sarasota, Florida) reported that its subsidiary, Med Enclosure, continues to report successful investigational results for both diagnostic and interventional patients in the Randomized, Prospective, Multi-Center Trial of the MedClose Vascular Closure System. Early results suggest differences in the time-to-hemostasis between diagnostic and interventional cases, with average times of 4.6 minutes and 15.3 minutes, respectively, which is consistent with expectations. The MedClose VCS is a catheter-based, plug-mediated system that is designed to seal femoral arterial puncture sites and reduce time to hemostasis and ambulation in patients who have undergone diagnostic and/or interventional catheterization procedures. CPC of America produces cardiology medical devices.

Empirical Technologies (Research Triangle Park, North Carolina) reported that it is readying its BPGuardia for commercial deployment. The BPGuardian makes it possible to monitor blood pressure beat-by-beat and non-invasively without discomfort, using a portable device worn on the wrist. Information from the sensor is then sent via a Bluetooth connection to a nearby computer or handheld device, such as a PDA. Initial prototype development, testing and evaluation for the device was made possible by Center for Commercialization of Advanced Technology (CCAT) grants provided in 2005 and 2006 through the Office of Technology Transfer and Commercialization (OTTC) at California State University, (San Bernardino). SunTech acquired an equity position in Empirical Technologies in March 2006, and the two firms are collaborating to introduce a clinical blood pressure monitor that measures aortic pressure at the wrist.

EP MedSystems (West Berlin, New Jersey) reported the launch of its MapMate Interface link between its EP-WorkMate Recording System and CARTO XP Navigation and Ablation System. The CARTO XP System, from Biosense Webster, is a 3D navigation system used in advanced ablation procedures for treatment of patients with irregular heartbeats. The MapMate interface was recently cleared by the FDA. The MapMate Interface between EP-WorkMate and Carto XP System was designed to simplify procedures by having the recording system and the 3D navigation system communicate with each other to combine diagnostic data from each system and eliminate duplicate demographic data entry. Currently most labs must separately enter and manage patient data on their individual recording and navigation systems. By linking the detailed electrograms from sites within the heart to the “roadmap” used in conducting ablation procedures, MapMate Interface allows clinicians to rapidly see complete information to conduct the proper course of treatment, and produce comprehensive case reports from the EP-WorkMate Recording System. EP MedSystems develops cardiac electrophysiology products used in imaging, diagnosing and treating certain cardiac rhythm disorders.

In other EP MedSystems news, Royal Philips Electronics (Amsterdam, the Netherlands) reported the new ViewMate II ultrasound system based on Philips Medical Systems’ HD11 XE platform for use with EPMD’s ViewFlex intracardiac (ICE) imaging catheters. As part of this joint development and distribution agreement, Philips will also offer an ICE option to its customers on the HD11 XE ultrasound system. ICE imaging has been shown to reduce procedure time and X-Ray exposure in procedures such as transseptal catheterization, complex arrhythmia ablation and guidance of septal defect closures. EP MedSystems makes cardiac electrophysiology products used in visualizing, diagnosing and treating certain cardiac rhythm disorders.

Medtronic (Minneapolis) reported the release of its newest version of the Paceart System. The latest edition of Paceart further supports clinicians with solutions designed for the management of patients with cardiac rhythm disease. The system consolidates detailed data from in-clinic device interrogations from the major implantable cardiac device manufacturers, and also remote management technologies. Paceart supports the management of data for more than 1,000 implantable cardiac devices. In addition, Paceart serves as a single integration point, reducing the number of interfaces and information technology resources needed to share information electronically with other systems.

Possis Medical (Minneapolis) reported that Mercy Hospital (Coon Rapids, Minnesota) was the first hospital to use its new AngioJet Ultra Thrombectomy System. The next-generation Ultra System, which was approved by the FDA in December for blood clot removal (thrombectomy), was used by physicians at the Mercy Heart & Vascular Center in multiple thrombectomy procedures over the past two weeks, the company said. Possis develops medical devices for the cardiovascular and vascular treatment markets.

Royal Philips Electronics (Andover, Massachusetts) reported the commercial release of Philips EP Navigator, an imaging tool supporting the treatment of complex cardiac rhythm disorders. EP Navigator combines pre-interventional 3D CT images of a patients’ cardiac anatomy with live X-ray fluoroscopy catheter position information in a single image The EP Navigator is available as an option with Philips Allura Xper family of cath lab solutions. Royal Philips Electronics specializes in diagnostic imaging and patient monitoring systems in healthcare.

Signalife (Greenville, South Carolina) reported that it is developing plans to submit an application to the FDA seeking clearance for its cardiac vest, described as looking somewhat like a sports bra and classified as a Class II device. The vest has been “extensively” used in testing in the Champ Car World Series open cockpit racing, the company aid. During those tests, the ECG signals allowed physicians to evaluate data previously unavailable when captured in the very harsh environment of a race car. Signalife said this contrasts with current cardiac devices, where noise and artifact “distort ECG recordings in an ambulatory setting.” The Signalife vest features electrodes about the size of a quarter embedded in a cloth fabric designed to provide an improved level of comfort.

Vascular Solutions (Minneapolis) said it received FDA approval of its PMA Supplement for the added indication for the use of the D-Stat Flowable hemostat for the reduction in the incidence of clinically significant hematomas in the implantation of a pulse generator (pacemaker or ICD) in anticoagulated patients. The D-Stat Flowable hemostat is a thick, yet flowable, suspension of collagen, thrombin and diluent that was originally approved for topical application in 2002. The flowable consistency of the D-Stat Flowable allows it to coat the pocket created in the prepectoral area during the implantation of the pulse generator component of pacemaker and implantable cardioverter defibrillator (ICD) implants. Particularly with patients on anticoagulant medications such as heparin and coumadin, the prepectoral pocket can bleed for a substantial period following the implantation, resulting in a pocket hematoma which can lead to infection or require surgical evacuation. Approval of the additional indication was supported by the Pocket Protector clinical study, a prospective, randomized, multi-center clinical study to assess the safety and effectiveness of the D-Stat Flowable hemostat in the prepectoral pocket during the implantation of a pulse generator (pacemaker or ICD) in an anticoagulated population.

Zoll Medical (Chelmsford, Massachusetts) reported receiving FDA clearance for the ZOLL E Series with Real CPR Help technology. Zoll’s Real CPR Help allows rescuers to instantly see and hear how well they are performing the rate and depth of CPR chest compressions. With this clearance, the E Series becomes ZOLL’s first advanced pre-hospital device to provide this instantaneous feedback. “Typical professional defibrillators on the market today only provide generic, ancillary support to rescuers when it comes to CPR performance,” said Richard A. Packer, president/CEO of Zoll. “Zoll’s Real CPR Help technology can provide rescuers with assistance beyond merely prompting them to start CPR, so they are better equipped to improve their CPR performance.”