Medtronic (Minneapolis) said last month that the FDA has approved its CardioSight Service, a service for cardiologists who are managing heart failure patients to monitor their patients to provide better care over time in order to adequately address problems when they arise. The service works with several Medtronic cardiac resynchronization therapy defibrillators or implantable cardioverter-defibrillators, the company said.

Valerie Lind, senior corporate communications manager for the Cardiac Rhythm Management business at Medtronic, told Cardiovascular Device Update, “Prior to this, the heart failure physicians haven’t had access to information that’s coming out of the defibrillator, and only the electrophysiologist ... gets a lot of the data and gets more comprehensive data than the heart failure physician ...”

Lind said that while the cardiologists and heart failure physicians don’t implant medical devices, “there is data within the medical devices that could be advantageous to these heart failure clinicians that would allow them to understand what’s going on with certain heart rhythm trends.”

CardioSight also allows clinicians to identify some of the trends and some of the “unique features that Medtronic has within its own devices.” For example, a new algorithm called the OptiVol trend “identifies in advance if a heart failure patient is experiencing an increase in fluid in the lungs.”

Lind said that fluid build-up in the chest is the reason behind most heart failure hospitalizations. Medtronic last December launched the InSync Sentry cardiac resynchronization therapy defibrillator system that it said was the world’s first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity, which is the area encompassing the heart and lungs (MDD, Nov. 10, 2004).

“Currently, it’s very challenging for heart failure physicians to reliably, efficiently and regularly monitor their patients’ heart rhythm activity or lung fluid levels,” said Randall Starling, MD, head, section of heart failure and cardiac transplant medicine in the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation. “Symptom-driven, immediate access to this data will aid the heart failure team” in caring for the patient.

CardioSight is a networked service. That service includes a monitor, which according to Lind looks something like an answering machine and acts like a “reader.” That monitor is hooked up to a typical analog phone line.

According to Medtronic, “at the touch of a button, data can be transmitted from the implantable device via the CardioSight Reader. By holding the Reader’s antenna (similar size and shape of a computer mouse) over the implantable device, the physician can quickly collect and download 90 days of the patient’s cardiac rhythm trends and patients patterns without a device programmer.”

The clinician’s server then “automatically processes the data and creates a report and send it via fax to the physician,” within minutes, Lind said.

“The ability to diagnose and manage changes in heart rhythm patterns and heart failure symptoms is an important innovation we believe will improve standards of patient care,” said Steve Mahle, president of Medtronic Cardiac Rhythm Management, in a statement. “Our devices can monitor and detect a wealth of clinical information, such as fluid buildup in the thoracic cavity with our new InSync Sentry system.”

Mahle added, “By pairing these implantables with ... access solutions like CardioSight ... we can help more physicians identify changes in a patient’s condition and modify prescribed therapies, which in turn may reduce hospitalizations.” Lind would not say how much the service would cost, but she said the entire network service is included in the cost. “It’s definitely something new that’s going to give them new insight into managing heart failure patients,” she said. “I think at some point they will see it as a standard of care in treating their patients.”

Elsewhere in the product pipeline:

• ATS Medical (Minneapolis) reported that it has achieved a second milestone in its development of the Particle Separation by Ultrasound (PARSUS) technology for auto-transfusion in cardiac surgery by creating a prototype of a working disposable made of medically compatible materials that separates in excess of 90% of lipid micro emboli. ATS said that development is regarded as new evidence of the feasibility of PARSUS, which enables effective filtering by ultrasound waves of the undesirable foreign particles that become mixed in blood during cardiac surgery procedures. The company said PARSUS would allow physicians to give back to patients lost blood in a safe and efficient manner, potentially reducing the many complications currently associated with blood transfusion. It said the technology has the potential for use in all patients requiring cardiac surgery procedures, including heart valve replacement or repair and coronary artery bypass. ATS said the technology addresses a market opportunity estimated at about $150 million. The company has exclusive worldwide rights to the PARSUS filtration for cardiac surgery. The technology is owned by ErySave AB, a Swedish research firm founded in 2000 by a team from Lund Institute of Technology and Lund University Hospital.

• Bioheart (Sunrise, Florida) reported that the U.S. Patent and Trademark Office issued the company a notice of allowance regarding its patent application 09/858,046, “Method for inducing angiogenesis by electrical stimulation of muscles.” The invention is based on research conducted by Dr. Shinichi Kanno and Dr. Yasufumi Sato, described in a 1999 article published in Circulation. The article explains that when the patented electrical stimulation sequence is applied to ischemic muscle, it significantly increases capillary density, thus increasing blood flow in the tissue. Bioheart is focused on repairing damaged heart muscle with its MyoCell product, a myogenic cell composition made up of adult muscle stem cells called myoblasts. The company believes the issued claims will allow it to combine its MyoCell product with the electrical stimulation sequence, which could increase the blood supply to the transplanted cells and increase their survival.

• BryanLGH Heart Institute (Lincoln, Nebraska) has performed its first implant in a study to investigate the safety and effectiveness of the Optimizer implantable pulse generator as part of a clinical trial sponsored by its manufacturer, Impulse Dynamics USA (Orangeburg, New York). The Optimizer System is designed to deliver electrical impulses to the heart for treatment of moderate-to-severe heart failure. The FIX-HF-5 (Fix Heart Failure 5) study will involve about 400 patients with New York Heart Association Class III or Class IV heart failure at up to 50 U.S. sites.

• Cholestech (Hayward, California), a manufacturer of point-of-care lipid diagnostic testing devices, has received clearance from the US Food & Drug Administration to market the high-sensitivity C-reactive protein (hs-CRP) test on the Cholestech LDX System for the measurement of CRP in whole blood or serum. The new test is expected to be available in late summer. The company noted that a landmark study published in a recent issue of the Journal of the American Medical Association said that hs-CRP is as strong a predictor of cardiac risk as conventional risk factors such as cholesterol. The study, conducted at Brigham and Women’s Hospital (Boston), also showed that hs-CRP adds predictive value when used in conjunction with lipid tests related to cholesterol. The study followed nearly 16,000 women aged 45 and older for 10 years, monitoring them for the occurrence of a first cardiovascular event. It demonstrated that women with the highest levels of hs-CRP had a three-fold increase in risk.

• Concentric Medical (Mountain View, California) said new data on the safety and efficacy of its Merci Retriever System, the first medical device cleared by the FDA to remove blood clots from the brain in patients suffering an ischemic stroke was published in the July issue of Stroke, the journal of the American Stroke Association. The study results were obtained from a multi-center trial including 141 patients treated at 25 U.S. hospitals. All patients were ineligible for tPA, a clot-dissolving drug. The treatment window in the trial was within eight hours of stroke onset. Forty-eight percent of the patients were recanalized, or had their blood flow restored. Study authors noted, “This rate is significantly higher than the established historical control of 18%.” They further stated, “Good neurological outcomes ... were more frequent at 90 days in patients with successful recanalization compared with patients with unsuccessful recanalization ... and mortality was less.”

• CryoCath Technologies (Montreal) said it has completed a beta launch of FrostByte, which it refers to as the first two-in-one convertible device that incorporates a clamp and a surgical probe (SurgiFrost) indicated for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. CryoCath and its marketing and distribution partner, ATS Medical, are launching the product globally. CryoCath has received European CE approval for the newly designed FrostByte and had previously secured FDA 510(k) clearance. The FrostByte clamp is designed to secure the contact point between the cryoablation probe segment and the cardiac tissue, thereby improving effectiveness and reducing procedure time, according to the company. The beta launch was held at six U.S. cardiac surgical centers. The company projected that the annual global market opportunity for FrostByte and SurgiFrost in all contemplated applications is more than $250 million. SurgiFrost uses a malleable, single-use cryosurgical probe developed to ablate cardiac arrhythmias. It is used while a patient is undergoing a primary cardiac surgical procedure such as coronary artery bypass grafting or mitral valve replacement and/or repair.

• CryoCor (San Diego) said it has submitted to the FDA the fourth and final module of its premarket approval (PMA) application relating to the use of its Cardiac Cryoablation System for the treatment of atrial flutter. The final module contains the clinical safety and efficacy data from a multi-center clinical trial in which 160 patients with atrial flutter were treated using the CryoCor system at 22 clinical sites between December 2003 and November 2004. All patients were evaluated for six months following completion of the procedure. The company said atrial flutter is the second most common supra-ventricular tachycardia (SVT), and estimates are that 200,000 new cases occur each year in the U.S. alone. It increases the risk of stroke as a result of blood clot formation in the heart, and in some cases may convert to atrial fibrillation, the most common SVT. The CryoCor Cardiac Cryoablation System is designed to treat cardiac arrhythmias through the use of cryoenergy to destroy targeted cardiac tissue. It has been approved in Europe since 2002.

• Endologix (Irvine, California) said it received FDA approval to enroll patients in its clinical trial using its Powerlink System to treat abdominal aortic aneurysm (AAA) in patients with large diameter aortic necks. If approved for marketing in the U.S., the Powerlink System would be the only endoluminal stent graft (ELG) for use in AAA patients with aneurysm neck diameters up to 32 mm. The FDA has allowed the company to include a large diameter Powerlink ELG in the ongoing suprarenal arm of its clinical study. This should accelerate enrollment and permit physicians to treat patients that cannot be treated with an FDA approved ELG, Endologix said. In addition, the company received approval to initiate a seven-center, 60-patient protocol using a large-diameter infrarenal cuff with its approved Powerlink bifurcated device. The two studies will permit Endologix to study alternative implant strategies to treat this subset of patients. The company said it expects to begin enrollment in both studies in the current quarter.

• Enpath Medical (Plymouth, Minnesota) said it has received FDA marketing clearance for the company’s steerable sheath and has signed an exclusive license and supply agreement with Bard Electrophysiology, a division of C. R. Bard (Murray Hill, New Jersey), for distribution of the product in the electrophysiology market. The company said the agreement is subject to the completion of intellectual property due diligence and Enpath attaining CE mark approval for the device. The FDA 510(k) clearance is for Enpath’s steerable sheath as a stand-alone device for a number of procedural indications, including interventional coronary, peripheral vascular and carotid artery access. The company said it is in early discussions with other potential partners regarding distribution of iterations of the product for other market segments.

• Possis Medical (Minneapolis) has released the AngioJet DVX and XMI Rapid Exchange Plus (XMI-RX+) Rheolytic Thrombectomy catheters. Over the past eight weeks the Company has been conducting pre-release evaluations for these two new catheters at select hospitals throughout the U.S. Possis designed the new AngioJet DVX thrombectomy catheter in response to doctors who asked for a more powerful device to clear thrombus from large arteries. By enhancing the company’s Cross-Stream technology, the DVX catheter has an enlarged area of effect and provides a five-fold increase in clot removal power. The DVX catheter joins the AngioJet Xpeedior catheter and Power Pulse Delivery as solutions for large-artery thrombectomy. The Possis AngioJet XMI-RX+ catheter represents the fourth generation of design, a small-diameter catheter with several improve- ments in handling. The XMI-RX+ is currently cleared for use in peripheral arteries and Possis anticipates coronary approval by early fall.

• Resverlogix (Calgary, Alberta) said it has filed a patent application on behalf of its wholly owned subsidiary, RVX Therapeutics, covering an expanded application of its Nexvas cardiovascular technology. It said RVX Therapeutics has discovered pharmaceutical compounds that have the potential to be used with medical devices such as drug-eluting stents. The technology is designed to control cholesterol-related diseases such as atherosclerosis by stimulating the body to produce ApoA1 protein, the primary component of HDL (“good” cholesterol), which results in increased levels of HDL.