Varian Medical Systems (Palo Alto, California) is struggling to commission Europe’s first full-service proton therapy center in Munich, Germany, and cannot predict when the doors will be opened to patients.

The setback with the Rinecker Proton Therapy Center (RPTC) poses a significant challenge to the boast by Varian CEO Tim Guertin that the company was on its way to building a “several-hundred million dollar proton therapy business.”

Varian, which makes medical devices and software for integrated cancer therapy systems, built a strong momentum last year toward that promise by adding a proton therapy capability with the January 2007 acquisition of Accel Instruments (Bergisch Gladbach, Germany), a private supplier of proton therapy systems for cancer treatment (Medical Device Daily, Jan. 30, 2007).

Proton therapy is considered the most advanced form of radiation treatment, using a particle accelerator to generate a beam of protons that can be targeted in three dimensions and more precisely deliver a high dosage of radiation to a tumor while sparing, or reducing, the damage to surrounding healthy tissue and organs

The Accel acquisition added $30 million to Varian’s annualized revenues in fiscal 2007.

In March 2007, Varian reported the commissioning of Accel’s super-conducting cyclotron at the Paul Scherrer Institute (PSI; Villigen, Switzerland), calling it the world’s first commercial cyclotron for routine medical use.

Varian’s takeover of Accel was roundly welcomed, from Munich to Albuquerque, New Mexico, where at the Particle Accelerator Conference in June 2007, scientists said the combination of Accel’s proton therapy technology and expertise with Varian’s expertise in image-guided radiation therapy, treatment planning, information systems, clinical workflow, manufacturing, service and distribution would give the world a fully integrated proton treatment system from a single company.

By December, Varian said the FDA had cleared its proton scanning algorithms that the company claims will give clinicians greater control over how proton beams are used to target tumors and other abnormalities(MDD, Dec 26, 2007).

What did not happen for Varian in 2007 was meeting the deadline imposed by its commissioning contract with the RPTC to open the first gantry and treatment room for patients on June 22.

By October, the supervisory board of the freshly completed € 150 million ($220 million) facility went public with its frustrations, explaining to patients who are awaiting treatment that while the hardware is ready, the delay is caused by “Varian’s obvious difficulties to debug the Accel therapy control software modules.”

Dr. Markus Rinecker of the supervisory board of ProHealth (Munich), which operates the Rinecker center, told MDD, “We have a long list of patients waiting for treatment. Some of them have literally died waiting for treatment because proton therapy was their last chance.”

Rinecker, the son of company founder Dr. Hans Rinecker, said, “We have seen massive delays. We do not understand what is causing all the delays. What we see is the hardware is working. Yet there are apparently a lot of issues with the software, with quality assurance and with the CE certification.”

He added: “We hear from Varian about specific technical areas, but I cannot tell you what is really keeping them from opening this center. We are not getting the big picture. Are they not capable? Are they confused by the merger with Accel? They do not give us any clues. Technically we should be there.

“I can only give you one side of this story,” he told MDD, adding, “I will be very eager to hear what you are able to learn from Varian.”

Lester Boeh, VP of emerging businesses at Varian, told MDD through a spokesman that the technology installed in Munich is by far the most advanced in the industry and “the commissioning work is continuing.”

He said, “We’ve made good progress on the hardware and are working on completing the software that controls the treatment delivery. We have technical beam operating on all of the treatment gantries.”

Boeh added: “There is much work to do, but we are confident we will be successful. We look forward to the day when the system is ready for patient treatment.”

He said that Varian is not publishing an anticipated start for treating patients, adding, “That is up to the clinic to publish, if they choose to do so.”

The new RPTC houses what is easily one of the largest medical devices in the world, at its heart a super conducting cyclotron built along the Isar River south of Munich.

The beams are piped into Europe’s first purpose-built center for proton radiation therapy to provide a complete hospital setting for the treatment of cancer tumors.

With four gantries to deliver beams in separate treatment rooms and a fifth treatment room featuring a fixed beam, the RPTC boasts a throughput capacity of 4,000 patients per year. That compares with what Rinecker estimated is 50 patients per year at the PSI in Switzerland.

Where European medical device makers wait for years to receive reimbursement approval for innovative therapies from state health insurance funds, the RPTC is in the enviable position of already having an approval for proton therapy.

“Proton therapy is recognized for the contract covering about 45% of Germans,” said Rinecker. “We are most eager to begin treatment for the patients who really can benefit from proton therapy, which is children. Children suffer the greatest effects from radiation therapy simply because they live longer and are still growing. Treating a tumor in the spine for a child is a very big help because it means fewer deformations as the spine develops, for example.”

The RPTC has a core staff of clinicians and nurses already in place.

“We could open the doors tomorrow,” Rinecker said.