REVA receives CE Mark for bioresorbable scaffold

REVA Medical, Inc. announced that it has received CE Mark approval for its Fantom drug-eluting bioresorbable coronary scaffold, which offers multiple and substantial performance advantages over first-generation scaffolds on the market.

Fantom is REVA’s first commercial product. CE Marking allows for commercial sales in Europe and other countries that recognize the mark. With the approval, REVA will commence selling in selected centers in Europe this quarter. Initial quantities of the product have been manufactured and are immediately available to support commercialization.

Commenting on the approval, Chief Executive Officer Ms. Reggie Groves said, “CE Mark approval for Fantom is a major milestone for the Company. It is the culmination of years of effort. As the patient population becomes increasingly acquainted with the appeal of bioresorbable scaffolds in general, versus metal stents, we believe they will come to ask for Fantom by name, based on our positive data and the increasing preference for Fantom that we expect leading clinicians will develop over time.”

Data from patients enrolled in the Company’s FANTOM II clinical trial were used to support the CE Mark application. The trial enrolled a total of 240 patients between March 2015 and March 2016. The Major Adverse Cardiac Event (“MACE”) rate through six months for all 240 patients is 2.1%, which compares favorably to commercial first-generation bioresorbable scaffolds.

The Company continues to follow and evaluate patients and plans additional data releases at major industry conferences in May and October of this year. As previously announced, the Company is currently pursuing a private financing to support its commercial launch of Fantom and its ongoing operating and capital needs, including followon clinical trials and new product feasibility work. The financing is anticipated to close before month end.

Minimally invasive brain imaging

Picture: University of Utah

With just an inexpensive micro-thin surgical needle and laser light, University of Utah engineers have discovered a minimally invasive, inexpensive way to take high-resolution pictures of an animal brain, a process that also could lead to a much less invasive method for humans.

A team led by University of Utah electrical and computer engineering associate professor Rajesh Menon has now proven the process works on mice for the benefit of medical researchers studying neurological disorders such as depression, obsessive-compulsive disorder and aggression. Menon and his team have been working with the U. of U.’s renowned Nobel-winning researcher, Distinguished Professor of Biology and Human Genetics Mario Capecchi, and Jason Shepherd, assistant professor of neurobiology and anatomy.

The group has documented its process in a paper titled, “Deep-brain imaging via epifluorescence Computational Cannula Microscopy,” in the latest issue of Scientific Reports. The paper’s lead author is doctoral student Ganghun Kim.

The process, called “computational cannula microscopy,” involves taking a needle about a quarter-millimeter in diameter and inserting it into the brain. Laser light shines through the needle and into the brain, illuminating certain cells “like a flashlight,” Menon says. In the case of mice, researchers genetically modify the animals so that only the cells they want to see glow under this laser light.

The light from the glowing cells then is captured by the needle and recorded by a standard camera. The captured light is run through a sophisticated algorithm developed by Menon and his team, which assembles the scattered light waves into a 2D or potentially, even a 3D picture.

Typically, researchers must surgically take a sample of the animal’s brain to examine the cells under a microscope, or they use an endoscope that can be anywhere from 10 to 100 times thicker than a needle.

“That’s very damaging,” Menon says of previous methods of examining the brain. “What we have done is to take a surgical needle that’s really tiny and easily put it into the brain as deep as we want and see very clear high-resolution images. This technique is particularly useful for looking deep inside the brain where other techniques fail.”

Now that the process has been proven to work in animals, Menon believes it can potentially be developed for human patients, creating a simpler, less expensive and invasive method than endoscopes.

“Although its much more complex from a regulatory standpoint, it can be done in humans, and not just in the brain, but for other organs as well,” he says. “But our motivation for this project right now is to look inside the brain of the mouse and further develop the technique to understand fundamental neuroscience in the mouse brain.”

Source: University of Utah

Magnetic micromachines can be controlled remotely inside the human body

Magnetic micromachines can be controlled remotely inside the human body by application of external magnetic fields, making them promising candidates for minimally invasive local therapy delivery.

For many therapeutic scenarios, a large team of micromachines is required, but a convincing approach for controlling individual team members is currently missing. We present a method for selective control of identical helical micromachines based on their spatial position. The micromachines are operated by uniform rotating fields, whereas spatial selection is achieved by application of a strong field gradient that locks all machines except those located inside a small movable volume.

We deliver experimental evidence of three-dimensional selective actuation with a spatial selectivity on the order of millimeters over a workspace large enough for clinical applications. Selective control of teams of helical micromachines may improve minimally invasive therapeutic approaches and may lead to more flexible local drug delivery systems or adaptive medical implants. As an example, we propose a concept for adaptive radiation treatment in cancer therapy based on selective switching of radioactive sources distributed inside a tumor.

Source: Brückenkopf GmbH

Spectranetics Receives CE for Drug-Coated Balloon

The Spectranetics Corporation announced that its Stellarex™ 0.014” Drug-coated Angioplasty Balloon (DCB) has received the CE mark. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease, and challenging critical limb ischemia (CLI) in patients.  The combination of the currently available Stellarex 0.035” and the new 0.014” line available in Europe expands Spectranetics’ comprehensive portfolio of next generation DCBs to treat complex disease states across the lower extremities.

Continue reading “Spectranetics Receives CE for Drug-Coated Balloon”

Boston Scientific Acquires Tissue Resection Device from Distal Access

Boston Scientific has acquired the gynecology and urology portfolio of Distal Access, LLC, a Salt Lake City based company that designs minimally invasive medical devices. The portfolio includes the Resectr™ Tissue Resection Device, a single-use solution designed to effectively remove uterine polyps.

Continue reading “Boston Scientific Acquires Tissue Resection Device from Distal Access”

Medrobotics Otolaryngology and Colorectal Robotic Surgery System CE Approved

Medrobotics Corp. received CE Mark regulatory clearance in Europe for colorectal applications with the Flex® Robotic System. Medrobotics is the first robotic company to offer minimally invasive, steerable and shapeable robotic products for colorectal procedures. With this expanded indication, the Flex® Robotic System becomes the first robotic surgical platform offering the ability to access hard to reach anatomy in both otolaryngology and colorectal procedures without the limits imposed by straight, rigid instruments.

Continue reading “Medrobotics Otolaryngology and Colorectal Robotic Surgery System CE Approved”