A medical device was developed in Aachen that has already helped thousands of people (4.4.)

In a hallway at Abiomed, two employees in lab coats sit concentrated at a microscope. "Today is my first day of trial," says the young man, who is being instructed by an experienced colleague. Abiomed would like to recruit up to 200 additional employees in Aachen over the next two to three years for the production of the "Impella" heart pump. "Basically, this is a manufactory, with a lot of manual work, perhaps comparable to the production of high-precision mechanical watches," says Abiomed Managing Director Dirk Michels.

The Impella heart pump was developed at the end of the 1980s by Thorsten Siess, an engineer with a doctorate. Dirk Michels joined the start-up shortly afterwards. The pump temporarily takes over the work of the heart, pumps blood through the body and thus ensures the uninterrupted supply of oxygen to the organs. During this support, the heart muscle has to do little work. Michels explains that he can recover and regenerate during this phase.

In Aachen, production is to be quadrupled in the coming years. Abiomed is investing around 40 million euros in a new building with production and clean rooms. The work has already begun, but there is no longer enough space for the almost 550 employees.

Impella is the only non-surgical heart pump approved as safe and effective in Europe, Japan and the United States alike. It is intended for patients who are undergoing an operation to reopen constrictions in the coronary arteries using balloons and stents (so-called high-risk PCI procedures) or who have suffered a sudden heart attack with cardiovascular failure.

Payam Akhyari, Director of the Clinic for Cardiac Surgery and Professor at RWTH Aachen University, explains the importance of this development. "Before the worldwide spread of Impella therapy, in the event of cardiovascular failure, the treating medical team only had a choice of using a miniaturized heart-lung machine." This so-called ECMO (extracorporeal membrane oxygenation) is used connected to the patient's circulatory system via two cannulas, usually on the groin vessels, in order to maintain the circulatory system. "In this procedure, however, both the entire heart and the pulmonary circulation are bypassed and the patient's blood is passed through tubes outside the body through a gas exchanger and a pump outside the body for the duration of the therapy," describes the cardiac surgeon. This increases the risk of life-threatening complications such as infections, stroke or severe bleeding. The Impella pump can therefore be offered as a minimally invasive and often gentler alternative to ECMO for patients with pumping weakness, mostly in the left ventricle. Professor Akhyari and his team have used the Impella pump on heart patients more than a hundred times over the past few years. At Abiomed in Aachen, more than 600 of these pumps are manufactured every week. According to Abiomed, more than 250,000 people worldwide have now been treated with it. But it was a long way until the product was ready for the market, according to inventor Siess and his long-time companion Michels.

Michels had also studied in Aachen at the RWTH and in the USA when he came into contact with Thorsten Siess in 1997. “Our first conversation was in October 1997, and we founded the company on December 23 of the same year.” The first major investors were biotech funds, some from the USA. But they usually rely on a quick return on their invested capital plus the highest possible profit. "We were concerned with something else: this idea of ​​bringing the product to and in the patient and helping as many people as possible," says Michels. Initially, the investors had the plan to develop a replacement for the large heart-lung machines used in thoracic surgeries. "But we preferred to develop a heart pump that can be inserted minimally invasively via the groin. And we pushed that forward as well.”

But around the turn of the millennium, the young company ran out of capital. "At first we only spent money," Michels looks back. With such an innovative high-performance technology, the development is of course not profitable at first. The Aachen-based company went bankrupt in 2002 because the old investors didn't want to inject any more money. But fortunately, according to an old company contract, the patents reverted to the inventor Siess. Almost all 60 employees could then be taken over in a kind of management buyout when the company restarted, reports Michels, who comes from Bonn.

The new investors were again biotech funds, this time from the USA and Israel, among others. “We always wanted to develop the product here and keep it here,” emphasizes Michels. But in Germany no sponsors were found. The first patient had already been treated with the pump in 1999, a woman from Belgium. "She was here for our New Year's reception in Aachen a few years ago," reports Michels. In 2005, the then Impella Cardiosystems AG was bought by the US company Abiomed, which the American David M. Lederman had founded near the city of Boston in the late 1980s. "This freed us from the clutches of venture capitalists," says Michels. With the purchase by the Americans and the joint integration, an almost symbiotic relationship developed. While Aachen stood for research and development, the American colleagues contributed their knowledge to open up the US market. In 2012/13, profits were made with the pumps in Aachen for the first time. The next big step came at the end of last year: the US company Johnson

The founders Siess and Michels welcome the takeover. On the one hand, there was always the risk of a takeover by a non-specialist financial investor, for example from China. "And of course there were and are risks for a company like Abiomed due to the corona pandemic and now the war against Ukraine," says Michels. Under the Johnson umbrella

Despite all the successes, the company continues to operate in a niche market, admits Managing Director Michels. Unfortunately, the technology from Aachen is not yet available to many people because it is not financed in their health systems.

Even if their company is now owned by a US corporation, the founders want to continue as long as possible. "For me, the job at Abiomed is pure satisfaction," says 54-year-old Dirk Michels. "My dream is that we create something permanent here and that our pump will still exist in 100 years, just like the company."