Medical Device Daily
and MDDs

Sometimes the solution is simple.

Complex molecules emerging from biotechnology labs in the form of miracle medications pose a problem for how to deliver them safely to patients. With traditional delivery in the form of a pill, the chemical effect spikes, but then dissipates after only a few hours. Alternatively, a single bolus injection of these potent drugs could prove toxic in some cases.

Constant delivery at low levels is a promising method being explored with syringe pumps, but Acuros (Berlin) may hold a better idea with osmoregulation, the first-ever commercial application of adjustable osmotic pressure, a technology secured in both the European and American patent offices by Humboldt University (Berlin).

A spin-off from the university, Acuros is the exclusive licensee of the technology and showed the pump for the first time at the annual Medica exposition in Dusseld rf this past November. An application for a CE mark is in process.

Helge Adleff, technology manager with Acuros, opens his hand to reveal what he calls a revolution in micropumps, a simple plastic device with no moving parts, no batteries, and costing just a few euros.

“Syringe pumps are bulky, expensive and they need cables for energy,” he says. “This is simple, something that a caregiver or a patient can easily use and carry around with them. And it is disposable.”

The plastic housing holds two chambers, one filled with a salt solution and semi-permeous fiber microtubing. The second chamber holds a membrane filled with the drug to be delivered.

By adjusting the salt solution and the length of the porous tubing, Adleff said a continuous flow rate for the chemical to be delivered can be regulated to run from a few days to several weeks, even for several months.

“This micropump is delivering 0.2 microlitres per minute and can run for five days,” he said, adding it is a pulse-free volume flow with no surge or variation in the flow rate.

“While I said there are no moving parts, that is not completely true,” Adleff said, pressing with his thumb a spring-loaded syringe that pushes the liquid into a one-meter- long intraveneous tube to prime the pump.

“Otherwise you would need to wait several hours for the liquid to fill the tube,” he said.

There is also a valve to turn on, or to turn off, the flow into the tube.

In addition to direct drug delivery for insulin, pain management and chemotherapy, Acuros is working with partners to adapt the technology for lab-on-chip diagnostics. The technology also holds promise in microfluidics and medical engineering for cell culture, microanalytics and microreaction technologies.

Q-MED to distribute Palomar’s products

Palomar Medical Technologies (Burlington, Massachusetts) said it has executed an international distribution agreement with Q-MED (Uppsala, Sweden) under which Q-MED will have responsibility for the marketing and distribution of Palomar’s professional light-based products for aesthetic treatment outside North America.

Q-MED is the producer of Restylane, one of the most widely distributed dermal fillers in the world, with more than 9 million treatments provided to date.

Palomar said the single-source availability of its products along with those of Q-MED “will provide physicians with a wide variety of treatment modalities to better meet the needs of their customers for a superior aesthetic treatment.”

The two companies said they also recognize that the potential synergistic effects that may be achieved using the firms’ products “may provide improved treatment options to customers.”

Palomar and Q-MED plan to collaborate on marketing campaigns, as well as arranging clinical symposiums, consensus meetings and advisory boards.

The companies said the expectation is that Q-MED will be an exclusive distributor in a major portion of Europe by the end of 2008 and a large portion of the rest of the world, excluding North America, by the end of 2009.

The transition from Palomar’s existing distributors to Q-MED will be on a country-by-country basis as the companies agree on the terms of each transition.

Palomar CEO Joseph Caruso said, “There is great potential in combining the effects of Palomar’s light-based systems with Q-MED’s range of dermal fillers and injectable implants. We ... believe Q-MED will leverage [its] existing international presence, large customer base and brand-name recognition to greatly expand the international sales of Palomar’s light-based aesthetic devices.”

Italian distributor signs on with CytoCore

CytoCore (Chicago), a company focused on early detection and treatment of reproductive-tract cancers, reported its first delivery of SoftPAP cervical cell collectors in Europe.

M.O.S.S. (Lesa, Italy), a leading medical equipment distributor, will be the first organization in European organization to launch the device, which is designed to enhance patient comfort and safety while improving the quality of cervical cell specimens for Pap testing.

SoftPAP is designed to collect a full 360-degree specimen from both the cervical canal and the outer surface of the cervix, resulting in what CytoCore describes as “a more complete and comprehensive specimen for Pap testing.” The company said clinical studies have shown that SoftPAP collects a better-quality specimen while reducing adverse events, primarily bleeding and spotting, by 95%.

“SoftPAP is a vast improvement over the current method which involves specimen collection using a wooden or plastic spatula and cervical brush,” said Dick Domanik, president/COO of CytoCore. “We plan to work with a leading Italian university to further document the important advantages offered by SoftPAP. We anticipate launching SoftPAP in Spain and Portugal during January and in the U.S. by the end of 1Q08.”