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St. Jude Medical Announces First Implants of the Genesis Heart Failure System's Aescula 1055T LV Lead--the World's First Bipolar, Steroid-Eluting Left Ventricular Lead.

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 10, 2001

New Lead Designed to Provide Left Ventricular

Stimulation in Heart Failure (HF) Patients

St. Jude Medical, Inc. (NYSE:STJ) announced today the first implants of the Aescula(TM) 1055T(a) LV lead, the world's first bipolar, steroid-eluting left ventricular lead. The Aescula(TM)1055T LV lead, a component of St. Jude Medical's Genesis(TM) system(b), is designed to provide biventricular resynchronization therapy in patients suffering from heart failure (HF)--a serious condition that affects over 15 million people worldwide.

The Aescula(TM) 1055T LV lead adds to St. Jude Medical's left-ventricular lead portfolio, offering several advancements to the unipolar Aescula(TM) 1055K LV lead(b) in addition to a number of distinct handling and performance features in a bipolar configuration.

The world's first implants of the St. Jude Medical Aescula(TM) 1055T LV were performed in early September by Andreas Schuchert, PD Dr. med., University Hospital Eppendorf, Hamburg, Germany and by Dr. Hung Fat TSE M.D., Queen Mary Hospital, The University of Hong Kong, Hong Kong. Dr. Schuchert implanted the lead with the Frontier(TM) 3x2 biventricular resynchronization device(b) in a 78 year-old male with dilated cardiomyopathy. Dr. Tse implanted the lead with the Integrity AFx(TM) AutoCapture(TM) Pacing System in a standard-pacemaker indicated 74-year-old female patient with sick sinus syndrome. This marks the first time St. Jude Medical's proprietary Beat-by-Beat(TM) AutoCapture(TM) Pacing System is also providing left ventricular stimulation therapy. Dr. Tse also implanted the new Aescula lead with the Frontier(TM) 3x2 device in a 57-year-old male with complete heart block post-AV nodal ablation. All the procedures went well, taking less than five minutes to position the lead in each procedure, and the devices are functioning properly.

"These implants represent an important milestone for St. Jude Medical as they signal a convergence of our most advanced and unique technologies--left ventricular stimulation, AFx suppression, and the AutoCapture(TM) Pacing System," said Michael J. Coyle, President the St. Jude Medical Cardiac Rhythm Management Division. "It is our hope that the bipolar Aescula(TM) 1055T LV lead, with its unique `S' shape will expand on our initial experience of our unipolar Aescula(TM) 1055K LV lead, providing ease of implantation and chronic stability."

With heart failure, the left and right lower chambers of the heart (ventricles) beat asynchronously and are unable to pump a sufficient amount of the blood to the body, contributing to shortness of breath, fatigue, swelling, and other debilitating symptoms. With 450,000 new patients diagnosed with HF each year in the U.S.--and most patients dying within five years of diagnosis--St. Jude Medical is pursuing resynchronization therapy as an important new approach to HF treatment. The Company is conducting several worldwide clinical trials featuring the Genesis(TM) system, which includes the Frontier(TM) 3x2 biventricular resynchronization device--designed to provide stimulation therapy; the Alliance(TM) Catheter Delivery System(b)--designed to facilitate implantation of the LV lead; and the Aescula(TM) 1055K LV lead. St. Jude Medical submitted the Aescula(TM) 1055T LV lead as an IDE supplement for the Company's PAVE and VecToR studies and expects to include the lead in these trials later this year.

Unlike a standard pacemaker that stimulates just one side of the heart, biventricular resynchronization provides simultaneous electrical stimulation for both the left and right ventricles with the intent of restoring the hearts normal ventricular activation sequence. Electrical stimulation is delivered from the stimulation device through the pacing leads (insulated wires that carry electrical impulses) to the heart, where the leads are affixed. While implanting leads to the right side of the heart is commonplace, left ventricular lead implantation can prove more difficult and time-consuming due to the tortuous left-ventricular vasculature. The 6.3 French Aescula(TM) 1055T LV lead, however, is designed with these challenges in mind.

The St. Jude Medical Aescula(TM) 1055T LV lead's key features include:
-- Innovative `S'-shaped distal tip--designed to facilitate optimum
steerability and positional stability

-- Super Pass(TM) coating--designed to increase lubricity for ease of passage
through torturous vasculature and the lead introducer

-- Polyurethane sheath--designed to reduce friction, increase durability, and
reduce abrasion

-- Steroid elution--designed to provide left ventricular threshold stability

-- Bipolar electrode--designed for improved pacing and sensing characteristics


Eric N. Falkenberg, Senior Vice President of St. Jude Medical Cardiac Rhythm Management Division's Global Research and Emerging Indications added, "The Aescula(TM) 1055T LV lead features the Company's innovative distal `S' shape designed to allow placement of the lead in a non-wedge position coupled with a bipolar configuration with steroid elution to reduce threshold rises. The distal silicone-only `S' shape and polyurethane sheath midsection are designed to simplify the often challenging task of left ventricular lead placement."

The Genesis system is commercially available in Europe where it features the Frontier(TM) 3x2 Model 5510 device which offers St. Jude Medical's proprietary Dynamic Atrial Overdrive algorithm designed for atrial fibrillation (AF) suppression. Additionally, the Frontier(TM) 3x2 is the only biventricular resynchronization device to incorporate a DDT mode designed to facilitate continuous synchrony with intrinsic heart beats in addition to stimulation-based beats.

Any statements made regarding the Company's anticipated revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2000 (see pages 4-6). Actual results may differ materially from anticipated results.

St. Jude Medical, Inc.( http://www.sjm.com ) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value.

(a) Submitted as an IDE supplement to the Post AV Node Ablation Evaluation (PAVE) and Ventricular Resynchronization Therapy Randomized Trail (VecToR) clinical trials

(b) Investigational device. Limited by federal law to investigational use in the United States.
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Geographic Code:1USA
Date:Sep 10, 2001
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