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Dr. Robert Ersek, Member of WorldMed Medical Advisory Board pioneered stents, stent grafts and stent valves in 1969!

WorldMed is proud to dedicate this newsletter to the life long achievements of Dr. Robert Ersek, one of the most respected members of the WorldMed Medical & Scientific Advisory Board.

Dr. Ersek is an internationally acclaimed surgeon. Recognized by his profession, he has published more than 100 articles and delivers lectures around the world. Dr. Ersek's publications range from reconstructive surgical methods to skin grafting and technical reports on the suction-assisted lipectomy process. Dr. Ersek has developed and invented unique procedures for many surgical techniques. He is dedicated to the highest standards in the medical profession, and is a highly sought after speaker and educator on plastic surgery.

Among his many activities, Dr. Ersek is a Clinical Assistant Professor of Plastic Surgery at Southwest Texas State University and an Instructor at the University of Texas. He is certified by the American Board of Plastic and Reconstructive Surgery and a member of the American Medical Association and the Texas Medical Association. He is affiliated with every major hospital in the Austin area.

Dr. Ersek is active in many civic organizations including the Austin Symphony and Ballet. He is a member of Austin Smiles, visiting remote countries to provide plastic surgery for the poor.

Enclosed in this newsletter is a copy of U.S. Patent No. 3,657,744 describing the pioneering work of Dr. Robert Ersek. Filed on May 8th, 1970, based on experiments conducted during 1968 and 1969, this work is now recognized as truly visionary. Dr. Ersek invented the first expandable stent, the first stent graft for bifurcated aortic-iliac aneurysm repair and the first endoluminal prosthetic heart valve. Dr. Ersek designed the very first endoluminal control handle for deployment. His diagrams depict the very first full length connecting bar struts. His diamond and connecting "Z" shaped stent designs demonstrate fully that zig zag shapes are essential for proper collapsing to allow for entry into a blood vessel with a low profile introducer.

WorldMed believes it has organized a great group of people to work together. We look forward to future developments coming from this team.

IVUS examinations and animal explants confirm TALENT's ability to flush fit and embed into a vessel wall!

Unlike other stent graft systems that lie on the inner surface of the blood vessel and encroach into the luminal flow path, the TALENT device embeds into the vessel wall. This embedding is facilitated by the design which features the nitinol stent protruding outwards from the graft material. The expansion force of the stent itself combined with the expansion force and compliance of the integrated polyurethane balloons serve to press the rounded stent protrusions into the vessel wall. This is done without piercing the vessel wall like hook systems, and this improves sealing, migration resistance, and also keeps the blood flow path lumen as open as possible to prevent thrombosis. Wall trauma is minimized. WorldMed's patents covering the technique for inlaying the stent material into the graft material are a key component to achieving this desired result.

Study of PERCUTANEOUS TALENT stent graft in animal aneurysm models begins at University of Connecticut

Michael J. Hallisey, M.D. of the University of Connecticut School of Medicine, winner of the 1997 SCVIR Gary J. Becker Young Investigator Award for his paper "A Transluminally Created Abdominal Aortic Aneurysm Model" is leading a study of our TALENT stent graft constructed with WorldMed's proprietary new ultra-thin, ultra-high strength polyester graft material. This thin wall graft material allows the TALENT system to be placed with a percutaneous entry (10-12FR for straight, 14-16FR for bifurcated) introducer system.

The focus of this study is to determine the clotting time of the thin wall material, with and without, pre-clotting through the side port of the introducer, as well as, determine the durability of the device, and reactions of the vessel wall.

This same research laboratory will serve as a physician training center for the percutaneous entry TALENT system.

The TALENT physician training program is lead by Dr. Frank Criado, a member of our scientific & medical advisory board, and principal investigator of the Phase I IDE study of the bifurcated TALENT.

Phase I U.S. IDE Enrollment for Bifurcated TALENT Completed

-- Implants were completed at the Union Memorial Hospital with Dr. Frank Criado, The Miami Cardiac & Vascular Institute with Dr. Gary Becker, Dr. Barry Katzen and Dr. Benenati, Montefiore Medical Center with Dr. Frank Veith, Dr. Jacob Cynamon, Dr. C. Bakal, Dr. L. Sanchez and Dr. T. Ohki, The University of Michigan with Dr. Hugh Beebe and Dr. David Williams, and The University of South Carolina with Dr. Renan Uflacker, Dr. Kurt Stahfield, Pittsburgh.

World Medical Scientific & Medical Advisory Board to Meet November 20th, 1997 at the Waldorf-Astoria Hotel, 18th Floor, 7-9 a.m. in New York City.

-- The World Medical Scientific & Medical Advisory Board is comprised of many top Scientists and Physicians in their field.

Cell Sodding Program Progresses - 9 Implants of a Low Profile Entry TALENT have been completed at The University of Arizona Animal Laboratory

The WorldMed program to lead the way in integrating LIVING CELLS with prosthetic materials, and to achieve superior long term patency results, as well as sealing is well underway! Six of these implants were performed with a proprietary cell sodding into graft material method.

CENTER-RAD Self Centering Radiation Delivery Catheter Developed by WorldMed

The WorldMed team has been the World's leading OEM supplier of localized delivery catheters over the past five years. The company also is moving forward with two proprietary designs, the PRO-CELL protruding needle catheter - U.S. Patent 17 claims (see May 1997 issue of World Medical News) and the CENTER-RAD self-centering radiation delivery catheter.

The primary application for these devices is to prevent restenosis in post angioplasty, or post-stented arterial vessels. The PRO-CELL is also utilized to inject thrombogenic agents through graft material into aneurysms to address back bleeding from lumbars.

The company's patented polyurethane balloon technology offers the ideal characteristics for localized radiation delivery:

1. Low inflation pressure.
2. Controllable inflation / deflation.
3. Self-Centering.
4. Low profile.
5. High durability.
6. Resists fragmentation
7. Hypoallergenic.

Latex balloons utilized by other firms, do not inflate with control, they suddenly surge. Latex balloons also are known to fragment in case of a burst and are known to cause strong allergic reactions, in addition latex balloons also do not self- center.

Self-Centering is believed to be very important to assure even symmetrical dispersion of the radiation for effective prevention of restenosis. The Center-Rad centers within the real center of the vessel, not just the open lumen.

New Exhibit Booth, Logo, Literature and Training Program introduced at CIRSE meeting in London - Sept. 28 - Oct. 1, 1997

Please see below a glimpse of the new World Medical exhibit booth which was first put to use at the CIRSE meeting in London. The great look of this booth is the result of discussions with members of all company departments. We wanted to represent the increasing success of the company, which is being led by the TALENT's image of life-saving innovation.

We are also showing the cover page of our new TALENT sales brochure. Todd Davenport and Carol Barbre led the charge to create this exciting new component of our marketing department's Autumn '97 campaign.

 TALENT device receives coverage in major textbooks...

James Yao, M.D. - "Techniques of Endovascular Surgery", Due for release Spring '98

R. White, C. Donayre, T. Chuter - "Endoluminal Vascular Prosthesis", Due for release November '98

Newsbits from WorldMed:

Mr. Erik Granby joins WorldMed as Quality Assurance Manager. Mr. Granby held similar positions at Symbiosis, producer of minimally invasive surgical instruments and at Intervascular a Florida based producer of FDA approved surgical vascular grafts.

Mr. Dave Morrow has joined WorldMed as Senior Invitro Test Engineer. Mr. Morrow held a similar position with Cordis Corporation.

Mr. Michael Moore has joined WorldMed as R&D/Production Support Engineer. Mr. Moore held similar positions with Depuy and Cordis Johnson & Johnson. Mr. Moore was part of a select group recruited into Cordis's CEP program, where he had the opportunity to work in a great variety of departments.

Mr. Michael Cropper has been promoted to R&D Engineer. Mr. Cropper has been a technician with the company for seven years. Mr. Cropper was a key contributor to implementing through the design control process and a number of important, product improving, enhancements to the TALENT device.

Ann Tunstall, Ph.D, Director of Clinical Affairs at World Medical Manufacturing Corporation has been accepted as a member of the Vascular Graft Committee of the Association for the Advancement of Medical Instrumentation (AAMI).

Clinical Staff Increases:

Mike Dayton, Senior Consultant Clinical Affairs - formerly Vice President of Technical Affairs at MinTec (now a Boston Scientific Company), producer of stent grafts. Prior VP Operations Intervascular, Vascular Grafts.

Chris Blivin, Senior Clinical Research Consultant - formerly held a similar position with Corvita, producer of stent grafts.

Judy Brown, Senior Clinical Research Consultant - former Study Coordinator for numerous vascular devices.

Christine Gallowitz, joins WorldMed as a Clinical Data Manager. She formally held a similar position with American Health Foundation, a cancer research company in New York.

Elizabeth Ives, joins WorldMed as a Clinical Data Assistant.

WORLDMED TO SPONSOR PRESENTATION OF 10 YEAR + HUMAN FOLLOW-UP DATA ON COVERED ZIG ZAG STENTS FOR ANEURYSM REPAIR-

Dr. Nicholas Volodos, a member of the World Medical Scientific and Medical Advisory Board, was the first in the world to implant a stent graft for pseudo-aneurysm repair in a human back in 1986. Dr. Volodos patented a stainless steel covered "Z" stent in 1984 (before all others except A. Balko of 1982).

Dr. Volodos will present slides of his 10 year followup of endovascular stent graft patients at the World Medical Scientific and Medical Advisory board meeting on November 20th, 1997.

A key element of WorldMed's A. Balko U.S. Patent No. 4,512,338 filed January of 1983, based on experiments conducted in 1982 "Process for Restoring Patency to Blood Vessels" covering self expanding stent graft system for aneurysm repair and occlusive disease, has been determined by patent counsel to be FUNDAMENTAL EARLY ART in the field. Section 6 reads "Also although the wire form has been illustrated in the form of side by side circular loops along the longitudinal coil extent, it should be brought out that the loops could extend back and forth longitudinally and progressively build up in a circular path to form a completed wire form." A "Z" stent brought to practice in 1982 well before others in the field.

Upcoming meetings and TALENT presentations

Sept. 17-20, 1997 - 9th Annual Comp.Course, Oakbrook, IL - Dr. J. Cynamon, TALENT Endo. Stent Graft Experience.

Sept. 17-20, 1997 - European Society of Vascular Surgery, Lisbon, Portugal - Dr. Zeigler, Experience with 18 TALENT implants.

Sept. 23-28, 1997 - Trans-catheter Therapeutics T.C.T., Washington D.C. - Dr's. R. White and B. Katzen, Endoluminal Stent Grafts-general topic, TALENT implants.

Sept. 28 - Oct.2, 1997 - C.I.R.S.E., London, England - (4 papers) Dr's. Uflacker, Machan, Capasso, Hausegger

Oct. 12-14, 1997 - American College of Surgeons, Chicago, IL - Dr. S. Taheri - Poster, Dr. M. Marin (Overview All Systems)

Oct. 12-15, 1997 - Frontiers in Vascular Disease, Pebble Beach, CA

Nov. 9-14, 1997 - Brooklyn Endovascular Conference, Brooklyn, NY - Dr. A. Balko (TALENT Experience)

Nov. 9-12, 1997 - A.H.A., Orlando, FL

Nov. 19-23, 1997 - 24th Annual Symposium, MONTEIFORE MEDICAL CENTER, New York, NY - Dr's. Veith & Cynamon

Nov. 30 - Dec. 5, 1997 - RSNA, Chicago, IL - Dr. J. Benenati, "Endovascular Stent Graft Overview"

Dec. 14-18, 1997 - I.E.S., Sydney, Australia - Dr's. Criado/Fry Presentation "Worldwide Results / Economics of Stent Grafting," TALENT Workshop.

1998

Jan. 11-15, 1998 - 10th Annual International Symposium on Vascular Diag. & Intervention, Miami Beach, FL - Dr's. Machan, Criado, Bui - LIVE CASE FROM MONTREAL

Feb. 8-12, 1998 - International Congress XI Endovascular Intervention, Phoenix, AZ - Dr. Pamler "The first 100 TALENT Implants in Germany"

Criado/Fry "The Worldwide Experience with TALENT - first 1000 implants"

Patents Held By World Medical Manufacturing Corporation (Partial Listing)

The Endovascular Revolution - Contributions from Many Great Individuals

The development of endovascular "peripheral disease" technologies, particularly aortic stent grafts, represents the collaboration of industry, science, health care providers, and even government, working at their very best in pursuit of worthy goals.
World Medical has been credited with going back into the archives and getting some of the original pioneers back involved with current developments. Here is a partial list of members of World Medical's endovascular device research team.
Dr. Robert Ersek, patented an aortic aneurysm repair stent graft system with expandable slotted tube stents, and also a stent graft heart valve back in 1970.
Dr. Alexander Balko was the first in the world to place a stent graft for aneurysm repair in animals in 1982. January of 1983 he filed a patent for his covered serpentine or coil shaped nitinol stent system. This patent has been acquired by World Medical.
Dr. Elliott Kornberg, patented his long leg, short leg bifurcated system (the industry standard) with stent metal beyond graft ends, migration prevention mechanisms and partial or full length longitudinal support bars back in 1984. World Medical Patent.
Dr. Nicholas Volodos was the first in the world to place a endoluminal stent graft for repair of an aortic aneurysm in a human patient back in 1986 in The Ukraine, based on his patent of a polyester covered stainless steel Z stent filed in early 1984. From 1986 to 1991 he completed 53 implants and published this work in the Journal of Angiology in 1991.

Howard Leonhardt, President

Product Developments of World Medical Manufacturing Corporation A Growing Portfolio...

TALENT Device Improvements In Progress, Under Testing...

Thicker push rod for improved pushability and kink resistance of sheath. Also provides a tighter fit within hemostasis valve for greater liquid injection pressurization of sheath to control stiffness and flexibility.

Beveled plunger of push/holding rod for easier deployment in tortuous anatomy.

Improved removal and repositioning system. World Medical was the first in the world to demonstrate in living animals the complete placement and removal of a stent graft in the aorta with an integrated system (see World Medical News - July 1996). We have improved the original system, providing greater ease of use.

New flexible tapered tip on delivery system. Designed to navigate through tortuous anatomy.

Our 15-40 mm inflation diameter POLYURETHANE BALLOON CATHETER will now be offered as a separate option apart from the TALENT introduction system. This catheter will not have the conical cone as is present on the TALENT introduction system placement catheter.

PTA Balloon at tip of placement catheter - to dilate stenotic vessels for easier entry.