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The MX Q&A

Increasing focus on economic and clinical data for reimbursement is requiring many medical device companies to look for ways to integrate payer reactions earlier into product design and development to be successful.

An American 'intervention'

After operating for 12 years as a successful Italian-based manufacturer of vascular interventional devices, Invatec opened its first office in the United States in September 2008. Tapping its expertise in industrial plastic-forming and extrusion, the medical device company launched in 1996 under the leadership of cofounders Andrea Venturelli and Stefan Widensohler. Invatec sells coronary, supraortic, peripheral, and RF products in Europe, Asia, and now the United States. Today, the privately held company offers 35 product families, including a full PTA balloon line, in 70 countries.

Jack Springer

To oversee its new U.S. operations in Bethlehem, PA, Invatec tapped industry veteran Jack Springer as president. Springer comes to Invatec with more than 15 years of experience in endovasuclar therapies at Abbott Labs and Cordis Encovascular, where Springer worked his way up to general manager. Most recently, he served as president and CEO of Neuromonics (Edina, MN), a supplier of reagents.

Springer talks with MX about how his previous experience will help him in his new post, the challenges he faces, Invatec's working alliances with physicians, and the company's plans for the next few years.

MX: What do you bring from your experience with Abbott Labs and Cordis Endovascular that will help you as president of Invatec U.S.?

Jack Springer: Throughout my career I have learned that companies and leaders must accept and respond quickly to change. Leaders must not only be open but actively look for changes in market dynamics. Companies need to be structured to stay ahead of the very competitive and fast-paced medical device field.

For example, we have been dedicated to peripheral solutions. By becoming the experts in one area and not spreading ourselves too thin, we strive to remain the name physicians associate with answers to their peripheral need. Hence, our extensive below-the-knee PTA balloon catheter line. It is easy in the competitive business world to get caught up in what everyone else is working on. We have to remind ourselves that we will be better off with focused energy. At the same time we also have to remain open to the possibility that we might have to work and rework our approach in order to end up delivering what our physicians and patients need.

What is the biggest challenge you face as president of U.S. operations?

The largest challenge is to bring our innovative technologies within reach of the thousands of U.S. physicians who have requested them. Our physicians are seeking to address their patients' evolving needs and are looking for innovative companies with like priorities. Invatec offers a business model that addresses such physician concerns.

We run Invatec in a way that allows physicians to feel comfortable to approach us for the technology they require. Those open lines of communication continue in our global offices. We are structured in a way that allows us to hear physicians' ideas and quickly make decisions on the potential opportunity presented to us. Our limited hierarchal structure leads to very fast upward and downward communication and decision-making. This setup gives us a competitive advantage over most larger, hierarchal structured companies.

Where did Invatec's intellectual property come from? How was it developed to this point?

Invatec has developed all of its technology and intellectual property in-house and in partnership with our physicians. As a vertically integrated company, we have strong capabilities at every point in medical device development. We then work with physicians to identify and bring to market innovative products that they deem essential and necessary to practice better medicine.

What U.S. clinical trials besides ARMOUR for Mo.Ma are currently underway?

Invatec is planning to launch up to five additional U.S. clinical trials in the next few years. Many of these will be for products that are currently available for use in Europe, and a few others will be new offerings. Additionally, we recently received conditional IDE approval for our Iliac stent study, which will begin enrolling in February 2009.

What is the target date for introduction of the Mo.Ma in the U.S.?

We have recently completed enrollment in the ARMOUR clinical trial and after completion of follow-up will be submitting 510(k) to FDA. We have not yet finalized a date for the introduction of the Mo.Ma but will be prepared for launch upon FDA clearance of the Mo.Ma device.

What are the benefits of the Mo.Ma system?

The Mo.Ma is an embolic protection device. The Mo.Ma system is very different from other devices that are currently available because it offers proximal protection as opposed to distal protection. It does not cross the lesion prior to deploying the product and therefore reduces the potential risk from emboli.

The device also allows the physician to establish embolic protection during carotid stenting before lesion crossing with the principle of blood flow cessation by "endovascular clamping" via common carotid and external carotid artery balloon occlusion.

Where do you see Invatec's business in the next year or, say, the next five years?

Given our solid technology base in polymer, metal and "surface treatment" with bioactive coatings, physicians should also watch for many new treatment concepts that are currently under development by Invatec in the interventional vascular space.

We believe that next-generation devices for vascular disease will most likely include some kind of bioactive substances. Invatec will continue to enhance its product offerings on the basis of in-house, vendor-independent technologies, which provide a huge opportunity for clinical studies before bringing next-generation "combo-devices" to the U.S. market.

What benefits will Invatec derive from opening its first U.S. office? Does manufacturing remain solely in Europe?

Many U.S. physicians, especially those who had access to our products via their international teaching assignments, encouraged Invatec to expand our operations in the U.S. Our launch, in the U.S., represents a tremendous opportunity to expand our strong base and continue to develop innovative new products. When it comes to developing new ideas, having a connection in the U.S. and the ability to integrate into the U.S. market is a must for any global medical device company.

We view introducing our products and launching clinical trials as only the beginning. Currently, products are manufactured in both Italy and Switzerland.

Which is the best-selling Invatec product?

Physicians continuously comment that the performance of the Amphirion Deep 0.014" OTW Balloon is unmatched. The design of the dedicated below-the-knee PTA catheter facilitates its use during challenging cases and allows physicians the ability to perform innovative techniques.

What do physicians like about the Amphirion balloon?

The Amphirion Deep provides optimized flexibility and trackability, the lowest in class crossing profile and anatomical conformability. The Amphirion is well complemented by our other balloon products that together make up Invatec's full line of 0.018-in. and 0.035-in. PTA balloon catheters.

Aside from the PTA balloon product line what other products will be introduced for sale in the U.S.? Are regulatory requirements keeping most of Invatec's products from the U.S. market?

Aside from the already available balloon product line, we also are able to offer the Diver CE, a rapid exchange clot extraction catheter. Through our worldwide distribution agreement with Lumen BioMedical we are now able to provide U.S. physicians with the FiberNet embolic protection device. We are anticipating the U.S. availability of the Mo.Ma device, which will add to Invatec's U.S. carotid portfolio. Our U.S. regulatory team is taking every necessary measure to make as many Invatec product families available in the U.S. as soon as possible. Physicians in the U.S. will see many other products coming their way in the future.

On a related topic, how does the regulatory climate differ between the U.S. and Europe?

The fundamentals of the U.S. regulatory environment differ from that of Europe. The European regulatory process focuses on the pillars of safety and performance. While both safety and performance are primary concerns of the U.S. regulatory climate, FDA is also concerned with overall product clinical effectiveness--demonstrated through controlled clinical trials. While each of Invatec's product families is respected by global physicians for its safety and performance, the U.S. regulatory team is working with the FDA to meet the regulatory requirements of demonstrating reasonable assurance of safety and effectiveness.

It is generally accepted that the healthcare sector will suffer less than other business sectors during this recession? Do you agree or disagree?
Almost all sectors of the economy have been affected by the economic downtown. However, given the importance of quality healthcare, we are hopeful that there will continue to be resources available so that the healthcare sector can deliver the quality tools necessary for a high standard of patient care.

What advice would you give to executives of medical device companies in this tough economic environment?

It is important that companies be prudent and fiscally responsible during these tough economic times. At Invatec, we do not believe in sacrificing the quantity or quality of our research and development efforts but have also taken measures to insure that we continue to invest in critical product development programs that will provide benefits to physicians and patients.

© 2009 Canon Communications LLC

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