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July 1996 Vol. 5 Issue 3

First Human Thoracic
Aortic Implant!

Two More U. S. Patents and Assignments.

T.G.A. Listing Received in Australia.

Dr. A. Balko Joins Research Team.

Initiation of New Studies.

Upcoming Meetings.


Two New Patents Issued To World Medical Mfg. Corporation related to TALENT" System

U.S. Patent No. 5,522,961 covering "Method of Construction of a Balloon Catheter" has been granted to H. Leonhardt on June 4th, 1996 and has been duly assigned to World Medical Manufacturing Corporation.

The patent covers methods of molding a low pressure, self centering, low deflated profile, controllable inflation polyurethane balloon and the attachment to catheter means.

A Notice of Allowability was received May 29th, 1996 from the U.S. Patent and Trademark Office covering "Method and Apparatus for Engrafting A Blood Vessel." This patent application covers fundamental aspects of the company's stent graft systems including the stent's ability to conform to a wide range of blood vessel sizes and shapes while maintaining a sufficient blood tight seal with continuous outwards force of the Nitinol spring material.

Another World First for St. Vincents Hospital and World Medical's TALENT" Device!

We report our first human implant of the TALENT" system into the THORACIC AORTA of a patient as compared to the previous implants into the Abdominal Aorta and Iliac blood vessels. This TALENT" implant is to the best of our understanding the WORLD'S FIRST endovascular implantation of a COMMERCIALLY AVAILABLE THORACIC STENT GRAFT. Previous implants have been done with systems fabricated in a home made manner by Physicians.

Location: St. Vincents Hospital, Melbourne, Australia.
Patient: 27 year old gun shot victim.
Date of Implant: 6/20/96.
Physicians: Peter Mossop, M.D., Interventional Radiologist, Dr. Michael Denton, Vascular Surgeon.
Dimensions of thoracic aortic aneurysm: 3cms L x 6cms W growing rapidly.
Implant: 22mms x 5cms straight, .020" Nitinol spring stent fully supported covered with 0.18mm thick polyester (Dacron) graft material.
Time of procedure: 2 hours.
Summary: Aneurysm thrombosed immediately. Delivery system provided complete control of positioning. Seal was immediately good. Patient is well. We have 48 implants to date in animals and humans with no incidence of leaking or migration.


The T.G.A. (Therapeutic Goods Administration) of Australia has granted a listing no. for the TALENT"
Endoluminal Spring Stent Graft.

Listing no. AUST L 56049.

This listing allows World Medical Manufacturing Corporation to market the TALENT" system for various blood vessels to all properly qualified Physicians in Australia. Physicians are required
to complete training before use.


Dr. Alexander Balko Joins Worldmed Research Team!

Dr. Alexander Balko is credited as being amongst the very first physicians to implant a stent graft. In 1982 Dr. Balko, Assistant Professor of Surgery at the time at Brown University, implanted into animals a Dacron covered Nitinol serpentine stent. Later he repeated the experiments with a thin polyurethane covering. J Surg Res 1986; 40:305 -309.

Dr. Balko will actively participate in the company's NO-GRAFT aneurysm
filling catheter system
development project. Dr. Balko will be the primary researcher. Animal experiments are in process now. Dr. Balko will also actively participate in the PRO-CELL" endothelial cell seeding development project.

Dr. Balko has assigned to World Medical Manufacturing Corporation his U.S. Patent No. 4,512,338 filed January 25th, 1983 covering "Process for Restoring Patency to Body Vessels" - Nitinol stent graft system with control handle for sheath and occlusion balloon.

This is an early fundamental patent in the field which covers a design utilizing a collapsible Nitinol stent covered with Dacron or polyurethane. Claims of the patent include; an occlusion balloon for lowering blood pressure at deployment site, a push rod, a sheath handle offering ability to manipulate position. Among the many embodiments described, one claims a straight Nitinol wire inserted with a very low profile that upon exiting sheath and heating to blood temperature transforms into a stent with enough force to seal a prosthetic graft to an aorta wall.



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