Article

COMPANY PROFILE: INTERVENTIONAL TECHNOLOGIES, INC

Since its inception in 1984, San Diego-based Interventional Technologies, Inc. has been an industry pioneer in developing microsurgical devices and approaches that have improved clinical results at lower overall costs. Chairman and Chief Executive Officer Bob Reiss, a recognized leader in interventional cardiology, cofounded the company along with Carl Hays, a private investor. SMC Corporation of Japan, and two Palo Alto venture capital firms - Sutter Hill Ventures, and Wilson, Sonsini, Goodrich and Rosati, facilitated early venture capital funding. Many of the core executives, including Reiss, participated in the successful evolution of the medical device industry in San Diego. These included companies like Sharp Labs, IVAC, IMED (Alaris) and Advanced Cardiovascular Systems (now part of Guidant).

Reiss has brought together from many of these companies a group of highly qualified, experienced professionals in varied fields that include metallurgy, chemistry, chemical engineering, mechanical engineering and bioengineering. Walk the halls at Interventional Technologies and you're apt to meet employees from Australia, China, Malaysia, Russia, Philippines, Singapore, Taiwan, Thailand - more than two dozen countries worldwide. This diverse research and development team is reflective of San Diego's burgeoning multicultural biomedical industry.

Cardiovascular disease is the leading cause of death worldwide. In fact, in the United States, it's estimated that cardiovascular disease costs patients and businesses about $350 billion each year.

Although coronary bypass surgery has been a major breakthrough, the procedure has not been without both clinical and financial costs. Doctors began looking for less invasive approaches with better long-term outcomes. The next phase for treating coronary heart disease - interventional cardiology -- was made possible with various engineering breakthroughs. Interventional cardiology enables cardiologists to treat the heart and blood vessels from inside the vessels themselves. In 1999, more than one million interventional procedures were performed worldwide.

New medical issues, however, now face doctors - restenosis (the reclosing of the artery after treatment - about 30 to 50 percent of angioplasty patients experience this) emerged as a new threat. This is a direct result of the trauma associated with angioplasty. The challenge is to create effective clinical treatments for cardiovascular disease while containing spiraling health care costs, especially those associated with repeat procedures.

Interventional Technologies' products are helping to combat this. The company's major contributions have been in the field of microprecision fabrication techniques as applied to cardiovascular products. Some of these include: guide catheters, guide wires, microsurgical dilatation catheters, site-specific drug delivery catheters (injecting drugs, gene therapy or radio-pharmaceuticals directly into the coronary artery wall) and a photo-mask-and-etch-on-a-tube chemical milling manufacturing process for cardiovascular stents.

Interventional Technologies has a core group of six patented products:

The Cutting Balloon® -- The company's flagship product, the Cutting Balloon uses microsurgical dilatation to open diseased arteries without provoking the hyperplasia that can lead to restenosis. Longitudinally mounted blades relieve the hoop stress in the artery. The balloon is folded to shield the blades and protect the vessel wall as the catheter is passed to and from the lesion.
The Infiltrator®/Irradiator™; -- This product delivers a precisely controlled dose of a therapeutic compound directly into the arterial wall. Its injection ports are less than the diameter of a human hair and are shielded until the target site is reached. The Infiltrator/Irradiator is paving the way for innovative applications such as delivering gene therapy and radiotherapy into the arterial wall.
TEC® (Transluminal Extraction Catheter) System - The only device that simultaneously excises and extracts plaque and thrombi. Studies show lower rates of distal embolization and myocardial injury when TEC is used before angioplasty as compared to balloon angioplasty alone.
LP Stent™ -- Stents are tiny metal scaffolds used to prop open diseased arteries treated with balloon angioplasty. While several companies manufacture and sell stents for coronary arteries, Interventional Technologies uses a unique design and patented manufacturing process to give the LP Stent the capability of penetrating and supporting the artery with less pressure-trauma, potentially reducing the rate of restenosis. The stent design improves vessel wall penetration and requires less delivery and final placement pressure. The LP Stent also has a much smoother surface finish and higher crush resistance. It is deployed with less pressure than needed to expand first or second generation stents. One version of the LP Stent is a covered stent, which when coupled with TEC atherectomy, represents a state-of-the-art solution to embolization problems associated with treating degenerated saphenous vein grafts.
TrackWire® -- This family of guidewires uses proprietary processes and new aerospace materials to provide higher levels of control and support. TrackWire twists and turns to negotiate difficult vasculature at the doctor's command.
FullFlow® -- A perfusion dilatation system, FullFlow mechanically dilates arteries without blocking blood flow. It represents one of the most significant improvements in angioplasty since cardiologists starting using balloons in the late 1970s, and is opening up opportunities in radiotherapy applications.

The success of Interventional Technologies over the years is due to a number of factors. Seasoned product engineering and manufacturing process development teams have been instrumental in design breakthroughs. The company provides an array of products that broaden physicians' options and create opportunities for more effective treatments. In addition, physicians are consulted on a regular basis in order to identify clinical needs that might be solved by the company's expertise in design and fabrication. In fact, individual physician input has been integral for most of Interventional Technologies' products.

Interventional Technologies is a true "Pacific Rim" company. About 70 percent of its sales are to Japan. Other key markets are China, Malaysia, Singapore, Korea, India and Taiwan. Many Asian nations don't develop their own medical device products so Interventional Technologies anticipates a growing market in these areas over the next 10 years. The company also manufactures and distributes its products from Letterkenny, Ireland. The Irish manufacturing and distribution facility supplies customers in Africa, Canada, Europe and Latin America.

Although Interventional Technologies has recorded many breakthroughs, 1998 in particular was a very productive and active year. A St. Paul, Minn.-based company signed an agreement with Interventional Technologies to provide its pericardial tissue cover on a nonexclusive basis. The company's TrackWire family of guide wires was approved for sale in the U.S., Europe and Asia. The company's latest LP Stent product was awarded the CE Mark, facilitating sales in Europe, Canada and certain Asian countries. Finally, the company signed a letter of intention with a German biotech company for a unique gene therapy using the Infiltrator.

The FDA also approved Interventional Technologies' drug delivery catheter for a Phase 1 human clinical trial at the University of Alabama. The Infiltrator will be used to investigate the potential of using intramurally delivered ethyl alcohol to reduce restenosis associated with intracoronary stenting. Because the Infiltrator controls the injection of therapeutic agents directly into the arterial wall, it has advantages over alternative systems, including reducing adverse systemic effects, rapid and efficient drug delivery, and increased effectiveness of the therapeutic agent. Interventional Technologies believes the study will usher in a new era of cardiovascular medicine of site-specific drug, gene and radiopharmaceutical delivery and open new pathways for improving the prospects for those suffering from coronary artery disease.

Three other major news events highlighted the year. The company completed its first FullFlow clinical trials in Europe. Interventional Technologies was ISO 9001 certified. The certification applies to the company's operations in both San Diego and Murietta, CA; its operations in Ireland were previously certified. The certification will facilitate international sales efforts, as many countries now require independent ISO 9000 certification for medical device companies. Lastly, the company announced the publication of an important paper that explains the benefits of the Cutting Balloon angioplasty catheter.

As published in Circulation magazine (a journal of the American Heart Association), a study conducted by the Dokkyo University School of Medicine in Japan discovered that the Cutting Balloon induced less neutrophil activation, a clinical indicator of less vascular injury and subsequent inflammatory reaction. It suggested that less injury and inflammation might be the explanation for the lower restenosis rate after Cutting Balloon angioplasty as compared to conventional procedures.

Looking ahead into the 21st century, Interventional Technologies will continue to be an industry leader and contribute to the community. Interventional Technologies and its employees support many San Diego cultural activities including the many museums and thematic institutes located here. Interventional Technologies will continue to develop engineering and technology solutions in interventional cardiology that will help medical progress, reduce health care costs, improve the quality of life - and save lives.

Return to: Articles Index