Medical Device Daily

Symphony Medical (Laguna Hills, California) said it is starting patient enrollment in a Phase II multicenter trial of its treatment for post-operative atrial fibrillation (AF), a problem that plagues patients and cardiovascular surgeons, occurring in more than 30% of coronary artery bypass patients and up to 60% of patients who undergo a combination valve replacement and bypass procedure.

The company, a developer of biologic and biopolymer therapies for atrial fibrillation, said its treatment for AF is “non-destructive.“ The goal for the treatment, other than the hoped-for benefits relative to patient care, is to reduce hospital length of stay and cost of care.

“Physicians recognize the acute and long-term implications related to post-operative AF, including the potential for higher incidences of post-op stroke and the development of chronic atrial fibrillation,“ said Raymond Cohen, CEO of Symphony Medical. Cohen, who also serves as chairman of Cardiac Science (Bothell, Washington), was named to the Symphony Medical position in late May.

He also said that cardiologists are “virtually unanimous in their view that a prophylactic approach that prevents post-op AF treatment.“ He said that cardiologists consider the current standard of care as, “at best, inadequate and ineffective.“

The current standard of care requires the administration of drugs, including beta-blockers, amiodalorone and sotatol.

Cohen told Medical Device Daily that, “In fact, there were some studies done where some fairly large numbers of patients were given these drugs, and they tried to decrease the post-operative atrial defibrillation.“

The “best they could do“ was to bring the prevalence of AF from 37% to 19% having AF, he said.

“When you think about it, 19% of all patients still having untreated atrial fibrillation post-operatively is pretty bad,“ Cohen said. “And it didn't impact their length of stay.“

He added that such drugs also are “very aggressive“ and come with potential toxicity to the patient.

Symphony Medical said that a reduction in length of stay of even half a day can lead to “significant cost savings.“ The intensive care unit (ICU) cost for a day averages $2,800, the company said, since post-operative AF is “most frequently seen two to three days after surgery.“

The company said that the financial impact to hospitals of post-operative AF represents “the most important potentially reversible“ healthcare expenditure related to cardiothoracic surgery, with annual costs estimated to exceed $1 billion in the U.S. alone.

The Symphony Medical treatment kit has three components: a hemostatic sealant derived from human plasma, a disposable two-channel applicator to facilitate delivery of the biopolymer and a disposable, hand-held electrical stimulation device used to accurately detect the precise location of the injection.

The hemostatic sealant does not include any components derived from animals. It is supplied to Symphony under an exclusive licensing arrangement by Omrix Biopharmaceuticals, and it is approved in both the U.S. and European Union.

The biopolymers are injected into the heart at the SV node and AV node, after a surgeon finds the best location near the epicardial fat pads using the electrical stimulator device, Cohen said.

The company said “it is believed that the administration of the biologic material into the epicardial fat pads achieves temporary modulation of the autonomic nervous system of the heart by blocking the vagal inputs to the heart that can serve as an initiating trigger for atrial fibrillation.“

The company's studies up to this point indicate that the biological material that is injected dissipates in less than 30 days after being injected into the heart.

The current Phase II trial is a 40-patient, open-label study being conducted at multiple sites in Europe, including the German Heart Center (Munich, Germany) and the Dresden University Heart Center (Dresden, Germany). Those patients undergoing routine coronary bypass grafting and or heart valve repair will be enrolled in the study.

The endpoints for the study will include not only safety parameters, but also the incidence of persistent AF and/or AF requiring medical intervention during the first few days following surgery.

Cohen told MDD that Symphony Medical would seek approval for the treatment in Europe first, but that the company hopes to get trials under way in the U.S. in the near future.

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