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Volume 6 Issue 1 May 1998

As of May over 1,700 TALENT implants and 170,000 Poly-Cath catheters have been used Worldwide!

This is the 10 Year Anniversary of the founding of World Medical Manufacturing Corporation 1988 - 1998.

10+ years of continuous improvement, step-by-step.

Inside this Issue
  1. Coil-Rad introduced.
  2. Animal explants confirm embedding effect of TALENT stent.
  3. ISO 9001/CE Mark received.
  4. Phase II trial underway TALENT.
  5. Historical account World Medical.
  6. New patents issued.
  7. Talent AV (arterio-venous) study.
  8. Low profile system released for evaluation.

COIL-RADTM introduced for the prevention of restenosis utilizing radiation therapy.

The COIL-RADTM joins the CENTER-RADTM (self centering, multi-layered balloon catheter), The PRO-CELLTM (protruding needle catheter) and PHOTO-CATHTM (photo-dynamic therapy catheter) in World Medical's line-up of product developments currently being studied at for treating restenosis post angioplasty.

The COIL-RAD is a beta or low energy gamma radiation emitting agent coated stent made of a shape memory alloy (nitinol). The stent wire is delivered in a straight shape through a micro-guiding catheter (1-2FR). When the catheter is withdrawn and wire is exposed to the warmth of the blood, it reverts to a tight coil shape. This device is designed to get the radiation source as close as possible to the outer vessel wall and to provide full perfusion during treatment. The stent can be temporary or permanent. Length can be adjusted to treat any lesion size.

Nearly all aspects of the device except the radiation coating are covered in World Medical's A. Balko et. al U.S. Patent 4,512,338 filed January 1983.

The length of temporary stents can be adjusted easily to match precisely with every lesion just by controlling the length of wire exposed to the blood stream warmth. Temporary stents can be withdrawn back into the catheter with ease. The use of a cold injectate reduces any resistance of the retrieval. Permanent stents can be loaded in succession within the same catheter and can be butted up against each other to create adjustable lengths.

Phase II U.S. IDE for TALENT bifurcated system underway.

In February the company received conditional approval (additional data to be provided) from the FDA to begin a Phase II study of the TALENTTM bifurcated stent graft system for abdominal aortic aneurysms, starting in high risk patients.

ISO-9001 Quality Systems Certification Obtained.

World Medical is proud to announce that the NSAI (National Standards Authority of Ireland) has granted 'Registered Firm' status under ISO 9001 / EN 46001 certification, after a comprehensive 4 day audit in January 1998. The auditors commented that the design controls and internal audits of World Medical were some of the best they have ever seen. newsletter0598b.gif (1536 bytes)


World Medical has received CE Mark for it's TALENT Endoluminal Stent-Grafts for both Abdominal and Thoracic Aneurysms.

World Medical Manufacturing Corporation
Celebrates 10 Year Anniversary!

Officially this is only our 10th anniversary as a registered MANUFACTURING company, however, the actual origins of World Medical and the development of our flagship products, the TALENT and the POLY-CATHTM go back much further.

1969 - Robert Ersek, M.D. member of WM advisory board* invents expandable covered stent and stent valve w/delivery system.

1981 - H.J. Leonhardt writes business plan for World Medical while at Anoka-Hennepin Technical College, International Trade Program.

1981 - H.J. Leonhardt works summer at American Industrial Corporation (AIC) and shares business plan.

1982-84 - AIC owners form American General Medical Corporation and hire H.J. Leonhardt as first employee to start. Company grows to $9 mil. in sales, export of medical supplies and equipment.

1981-83 - Alexander Balko, M.D.* develops, patents and brings to practice covered serpentine nitinol stent and balloon assisted delivery system to repair aortic aneurysm. 1st endovascular implant in history to repair aortic aneurysm in animal.

1984 - Dr. Syde Taheri* develops foam cuff with balloon driven staples type endoluminal stent-graft.

1984 - Nicholas Volodos, M.D.* invents in the Soviet Union Dacron covered stainless steel Z stents for aneurysm repair.

1984 - Elliot Kornberg, M.D.* develops short leg, long leg adjustable length bifurcated graft w/longitudinal support struts, hooks/barbs, metal past ends of graft, resilient sealing stent.

1986 - World Medical Corporation is formed as export trading company specializing in helping small manufacturers to reach export markets. Cardiovascular products sold under World Medical label.

1986 - Dr. Volodos* completes first ever human implantation of stent-graft to repair aortic aneurysm.

1987 - World Medical Corp. $3.1 mil. + in sales. H.J. Leonhardt hires Richard Spencer* as consultant. WMC profitable.

1988 - World Medical Manufacturing Corporation formed to initially produce blood oxygenators with Labcor/DMG Brazil and thermodilution catheters. Ken Durbin, VP Quality/Regulatory is first employee. Poly-Cath¿ developed.

1989 - Allen Tower of Numed Inc. consults with World Medical on balloon catheter production. Flexible production line. Custom manufacturing.

1989 - Nippon Zeon Company of Japan ($2 bil. annual sales) winner of Deming Prize for Quality, purchases 10% of World Medical.

1990 - Adam Sanford* (board member) founder of Adam Spence Corporation, leading U.S. extruder of medical tubing for 30 years, consults with WMMC and handles all extrusions.

1990 - U.S. FDA 510k received for POLY-CATH¿ thermodilution catheters.

1991 - WMMC profitable.

1992 - Adam Spence, Millar Instruments, Betatherm and G. Cremascoli invest in World Medical.

1993 - Blood vessel patch developed.

1994 - TALENT device is developed for commercialization. Animal implants.

1995 - Pro-Cell patent filed.

1995 - Ken Thomson, M.D. performs 1st human implant TALENT.

1996 - More suppliers and distributors invest in WMMC. 1st thoracic implant.

1997 - TALENT captures market leadership overseas and FDA IDE study begins. (2nd AAA, 1st thoracic.)

1998 - COIL-RAD and CENTER-RAD developed.

1998 - CE Mark received for TALENT.

* Member of World Medical.

World Medical Manufacturing Sales
Growth in the Period from 1995-1998

World Sales Growth Chart

Narrative description of the history, nature and operations of World Medical Manufacturing Corporation.

TALENT Device Improvements In Progress, Under Testing.

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Indented Plunger to improve deployment.

Deflation time of balloon is improved with new lumen design and back-end.Testing of TALENT MULTI-STAGETM continues (see WM Newsletter 2/96 Page 5). The latest configuration of choice under testing comprises:

Patent Pending
Low profile 12FR o.d. sheath.

Stage 1 = Expandable foam graft, with nitinol center bar for support. Tissue adhesive is injected through sheath onto ends before deployment.

Stage 2 = Proximal and distal Balko serpentine stent with connecting bar, ultra-thin polyester fabric covering, stretchable material.

Stage 3 = Thin wall graft, shorter length than stage 2, with three Balko zig zag stents sewn in center.

Stage 4 = Duplicate of stage 2 with optional fibrin glue injected on outer surface - non-stretchable material. Human evaluation scheduled for end of year.

TALENT MAVIS, S. Taheri, M.D. - proximal control re-positioning system (strings from brachial entry attached to graft TO PULL GRAFT FROM SHEATH). Patent pending since 1996. In animal testing.
TALENT with foam cuff and autologous tissue adhesive.Patient's own plasma creates tissue adhesive which is injected through transparent sheath onto exterior surface of foam cuffs at proximal and distal ends of polyester covered TALENT stent-graft.25FR o.d. sheath released for grafts 32-36 mms.

Figur 8TM Marker System introduced to increase radiopacity, and aid in device positioning.

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Human study of low profile entry TALENT LoPro I system to begin at select foreign centers.

The TALENT LoPro ITM, the low profile 20FR introducer system stent-graft, for bifurcated aortic aneurysm repair, has been released for human evaluation to a limited number of centers after extensive lab and animal testing over the last two years.

This device features World Medical's proprietary ultra-thin (0.06mms wall), ultra-high strength, endovascular grade polyester graft material. The chemical formulation of the endovascular grade material was found to be indistinguishable from the original TALENT surgical grade (0.18mms wall) polyester graft material by an independent laboratory.

The low entry profile of the flexible introducer system, (balloon-less option soon available), should allow the TALENT LoPro I stent-graft to treat smaller patients than the original TALENT device. The company recommends that the low profile device be reserved for patients which cannot receive the surgical grade material due to exceptionally small femoral and iliac arteries, until long term data are gathered.

The TALENT LoPro II offering further reduction of entry profile should be released late summer 1998.

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Animal explants confirm TALENT's ability to impress into 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 impresses into the vessel wall. This impression is facilitated by the design which features the nitinol stent protruding outwards from the graft material. The expansion force of the stent itself serves to press the rounded stent protrusions into the vessel wall, without piercing the vessel wall like hook systems. This improves sealing, migration resistance and keeps the blood flow path lumen as open as possible to prevent thrombosis. In addition, this reduces trauma involved with piercing systems. WorldMed's patented technique for mounting the stent material into the graft material is a key component to achieving this desired result, our inlayed feature.


TALENT¬ AV (arterio-venous) Stent-graft Developed.

A specially adapted TALENT stent-graft has been developed for the A-V hemodialysis graft application. The compliance of the stents, the flush fit and the biocompatibility of the photo polymerized collagen coated polyester or ePTFE graft are all combined together in an attempt to reduce restenosis. Over 150,000 AV grafts are placed each year. Nearly 100% of these restenose within 1 year. World Medical is undertaking a series of animal experiments in preparation for a human study later.

CENTER-RAD Self Centering Radiation Delivery Catheter Under Testing.

A series of animal experiments to validate the safety, effectiveness and utility of the CENTER-RAD self centering radiation delivery catheter will be conducted. The first proposed application for the CENTER-RAD will be for treating placed TALENT AV (arterio-venous) graft attachment sites, in an attempt to further prevent restenosis, as an arm of the forthcoming TALENT AV study.

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Intravascular Injection Catheter Patent Issued.

U.S. Patent 5,693,029 H. Leonhardt was received 12/97 for "PRO-CELL Intra-Cavity Therapeutic Agent Delivery Device" and has been assigned to World Medical. A device with an inner balloon, nitinol hypodermic tubes, and needles that protrude from the catheter surface when the inner balloon is inflated. The design includes a number of embodiments for controlling precisely the depth of penetration.

This device was originally designed for fetal endothelial cell (obtained from placenta or cord blood) implantation into the adventitia of a diseased vessel in order to grow a new vibrant living liner inside the old vessel, utilizing the old vessel as a scaffolding. The device may also be used for depositing a photo-sensitive agent, localized drug delivery or for injecting through a placed stent-graft to occlude back bleeding.

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World Medical issued fundamental patent in field of endoluminal stent-grafts!

New Patent Issued to World Medical
"Apparatus and Method for Engrafting a Blood Vessel

Sunrise, Florida - World Medical Manufacturing Corporation has added to it's estate of over 11 patents in the cardiovascular devices field, Leonhardt, et. al. U.S. Patent No. 5,713,917 2/3/97. This patent describes a number of new advances (28 claims) in endovascular stent-graft technology. This patent is a continuation-in-part to previously issued U.S. Patent No. 5,591,195. The patent describes a self expanding, self conforming nitinol serpentine (zig zag) shaped stent with a portion enclosed (partially covered) within fabric graft material for the purpose of bypassing aortic aneurysms and for repairing other blood vessels. The design includes a bare un-covered stent, which is connected to the fabric covered stent with wide interstices which can be placed across, above or below branch vessels.

The patent covers a number of optional configurations including; graft material may be tapered to reduce bulk and the graft ends may have fabric material cut-out between each alternative crests of the zig zag pattern, to allow for greater variability of conformance, to improve incorporation into the tissue and to reduce thrombosis in smaller diameter vessels. One embodiment includes tissue adhesive, including photo-sensitive release, on the exterior surface of the graft to improve sealing. Another embodiment includes the use of foam cuffs to improve sealing and to reduce the bulk of graft material. A graft material composition option includes stretchable ends with non-stretchable center portion. Another added feature described is a retainer to control self expansion. Additional claims include; an integrated removal and repositioning system utilizing suture loops and a crank reel, a micro-emboli filter, a dilatation balloon at the tip of the introducer system, a nitinol core wire placement catheter, a non-sinkable cone to sheath connection, and a single entry bifurcated placement system.

"Our group holds the earliest in-force patent in the field of stent-grafts with the A. Balko patent no. 4,512,338 filed Jan. 1983 describing a covered self expanding, balloon assisted, nitinol zig zag stent for repair of aneurysms and occlusive disease. Dr. Balko was the first in the world to place a stent-graft for aneurysm repair in animal models in the early 1980's. We also hold rights to E. Kornberg patent no. 4,562,596 filed April 1984 which describes the industry standard short leg, long leg bifurcated design, adjustable length, stent metal beyond the ends of graft material, migration prevention mechanisms and longitudinal support struts (stent wire segments), all of which are essential for clinical success" states H. Leonhardt. Dr. Robert Ersek the physician who designed the very first aortic stent-graft in 1969 (U.S. Patent No. 3,657,744) and Dr. N. Volodos (SU A) the physician who first implanted a stent graft in a human patient to repair an aortic aneurysm in 1986, are also active members of the World Medical's Scientific Advisory Board and research team.

Newsbits from World Medical.

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World Medical's Customer Service Team:
Linda, Nancy, Rich, Catherine, Dee, Pat

Ms. Debbie Abels joined World Medical last fall as Senior Quality Assurance Engineer. Ms. Abels holds a Masters Degree in Quality Engineering and an MBA from Nova Southeastern University. Ms. Abels formerly served as Senior Quality Engineer for Telectronics (pacemakers) and as Biocompatibility Coordinator at Cordis Corporation. Ms. Abels was a key member in the effort to achieve ISO certification and CE Mark. newsletter0598k.jpg (9410 bytes)
Ms. Catherine Sulawske-Guck has been promoted to Director of Operations. Ms. Sulawske-Guck has worked with World Medical since 1989. newsletter0598l.jpg (9047 bytes)
Mr. Mike Moore has been promoted to Director of Manufacturing. Mr. Moore established the TALENT as the most brightly radiopaque stent, with his work in developing the Figur 8 Marker System. newsletter0598m.jpg (8386 bytes)


TALENT has been awarded the TEAM study in France. This award was given to World Medical after careful evaluation of all endovascular stent-graft systems. The trial should include more than 150 patients.

World Medical has received third party Certification (Federal standard 209E) of it's newly opened 2000 square foot Class 100,000 Clean Room, from MicroFiltrations, Inc. on February 13th, 1998. This is the third clean room at the World Medical headquarters. A fourth clean room is located in Galway, Ireland under the supervision of World Medical Europe, Ltd. and Qualtech, Inc. A fifth is located in Brazil with Labcor.

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World Medical has added four new buildings to it's campus in Sunrise, Florida over the last quarter for the expansion of production, research & development and clinical affairs.

World Medical has added video telephone conferencing to it's communication equipment Armentarium.  The Endovascular Training Center near Madrid, Spain is equipped with video teleconferencing equipment as well. When Physicians come to training workshops at the site, we will be able to connect via video phone to participate more actively in the workshop proceedings. We can even watch implants with the cameras positioned in the operating rooms. The 1st TALENT training workshop at this site took place in January with Dr. Patrizio Capasso, Dr. Maynar and Dr. Casteneda present as endovascular instructors. Please contact the company if you are interested in attending the next workshop.

World Medical Celebrates 10 Year Anniversary.

May 4th, 1998 Sunrise, Florida - Starting in 1988 with a couple of people and little more than a dream to apply science to build devices to help save human lives, we have grown over the last 10 years to become an organization providing a major contribution to our field.We are very much a product of modern times. An America based company financed initially with capital from Japan, producing primarily in Florida working in joint venture with counterparts in Brazil and in Ireland obtaining advice from Physicians and Scientists in The Ukraine, Australia and many other locations.We received our first two orders from China over the internet last week. And this summer we are participating in a "hands on" endovascular workshop near Madrid, Spain via a video satellite link to our office in Florida.Ninety percent of our sales have been outside of the United States in more than 60 countries. The first market that fueled our sales was Mexico and soon there-after Japan grabbed our top market position and held that position all the way to last year, when Germany became our largest market. Exports create new jobs! Certain principles have driven World Medical's management from the beginning:

A strong commitment to...

  1. World Class consistent Quality. Continuous Improvement. Strive to Build the product right the first time. Do it right.
  2. Continuous and rapid innovation. Steady small improvements.
  3. Superior Customer service. Responsiveness.
  4. Flexibility to adjust quickly to changing market needs of our customers and to focus on what really needs to get done at a particular time.
  5. Continuous Learning. Perhaps our most important commitment.
  6. Networking with others ie; Universities, Suppliers, Advisors, Physicians, Prototype Builders, Machine Shops, Other companies. World Medical's headquarters is only a hub of a much larger network spanning the globe.
  7. Assuring time is spent on Adding value for our customers.
  8. Operating lean with small flexible staff focused on customers and products. Doing more with less. Reducing wasted time.
  9. Widespread early feedback on new designs early in the development process. Lots of prototypes evaluated comprehensively.
  10. No internal functional barriers. We want everyone involved in doing what needs to get done when it needs to get done.
  11. Work simplification. Do not over complicate tasks. Get to the heart of the matter and get it done NOW. Keep things simple.
  12. Operating on an International basis.

Perhaps the most enjoyable part of participating in building World Medical has been the opportunity to apply continuous learning. In order to upgrade our knowledge base and improve, we continuously study and obtain advice from others. In this quest to learn the best way to operate a company, we have learned from the work of many great innovators and business builders which came before such as Bill Gates (Microsoft), Steve Jobs (Apple), Thomas Edison (GE), Henry Ford, Richard Branson (Virgin), James McKnight (3M), Michael Dell (Dell Computers) and Bill Hewlett and Dave Packard (HP). Within our own field, Earl Bakken (Medtronic), Bill Cook (Cook Inc.), Manny Villafana (St. Jude, CPI, ATS), Allen Tower (American Catheter, Numed), Adam Sanford (Adam Spence), John Abele & Peter Nicholas (Boston Scientific), Brad Jendersee, Scott Solano, Bob Lashinski (AVE) and William P. Murphy (Cordis).We decided to model ourselves after the best of these individuals and companies, but most closely after two groups; Hewlett Packard and AVE. These groups have unparalleled commitment to continuous education, innovation, technology and quality. They continue to re-invent themselves to meet changing market needs. And perhaps most important of all, they create a great work environment for their people. Providing a great opportunity to enjoy the experience of building a company that is doing great things for people. We continue to strive to follow their example.

We owe tremendous thanks to many people over the years who have helped us. We have learned a lot in the last 10 years.

The job is not done, we have more room to improve. We want our customers to feel that a purchase with us is an investment into newer and better products that will help them even more in the future.

No one is working harder to develop better performing devices for treating cardiovascular disease.

"Thank you for your support over these last 10 years!"
Howard J. Leonhardt, President & CEO

1998 Meetings/Congresses

Joint Vascular Meeting (SVS-ISCVS)
June 7-9, 1998 (San Diego, California) (20x10)

Joint Vascular Workshop
June 10-12, 1998 (San Diego, California)

Convergences - Live TALENT Cases
June 15-17, 1998 (Paris, France)
Joint Vascular Surgery & Radiology Meeting

European Summer Symposium
June 25-27, 1998 (Brussels, Belgium)

5th Annual Workshop on Endovascular Surgery
June 27-28, 1998 (Ajaccio, Corsica)

47th Annual Meeting of the Scandinavian Association Thoracic Surgery and the 18th Annual Meeting of the Scandinavian Society for Extracorporeal Technology
August 20-22, 1998 (Helsinki, Finland) (10x10)

European Association for Cardio-Thoracic Surgery
Sept. 19-22, 1998 (Brussels, Belgium)

Sept. 27-Oct. 1, 1998 (Venice, Italy) (10x10)

October 1-3, 1998 (Paris, France) (10x10)

TCT Meeting
October 7-11, 1998 (Washington, D.C.)

International Endovascular Symposium
December 1998 (Sydney, Australia) (10x10)

Two physician instructional booklets describing step by step the procedure of implanting the TALENT endoluminal stent-graft based on the individual authors experiences are now available. One is published by Dr. Frank Criado, an experienced Vascular and Endovascular Surgeon (Fax: ) and the other is published by Dr. Bao Bui, an accomplished interventional radiologist (Fax: ). The instruction provided in these booklets represents the author's own personal preference and is not meant to replace the company's Instructions For Use provided with the product.

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