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.

3D Printing Customized Vascular Stents

Northwestern Engineering’s Guillermo Ameer and Cheng Sun have teamed up to use 3-D printing to develop flexible, biodegradable stents that are customized for a specific patient’s body.

“Right now, the vast majority of stents are made from a metal and have off-the-shelf availability in various sizes,” said Ameer, professor of biomedical engineering in Northwestern’s McCormick School of Engineering and professor of surgery in the Feinberg School of Medicine. “The physician has to guess which stent size is a good fit to keep the blood vessel open. But we’re all different and results are highly dependent on physician experience, so that’s not an optimal solution.”

Supported by the American Heart Association, the research is published online in the journal Advanced Materials Technologies. Robert van Lith, a postdoctoral fellow in Ameer’s laboratory, and Evan Baker, a graduate student in Sun’s laboratory, are co-first authors of the paper.

When ill-fitting stents move in the artery, they can ultimately fail. In these cases, physicians have to somehow re-open the blocked stent or bypass it with a vascular graft. It’s a costly and risky process.

“There are cases where a physician tries to stent a patient’s blood vessel, and the fit is not good,” Ameer said. “There might be geometric constraints in the patient’s vessel, such as a significant curvature that can disturb blood flow, causing traditional stents to fail. This is especially a problem for patients who have conditions that prevent the use of blood thinners, which are commonly given to patients who have stents. By printing a stent that has the exact geometric and biologic requirements of the patient’s blood vessel, we expect to minimize the probability of these complications.”

To create these customized stents, Ameer worked with Sun to adapt a 3-D printing technique, called projection micro-stereo-lithography, to fabricate stents using a polymer previously developed in Ameer’s lab. The technique uses a liquid photo-curable resin or polymer to print objects with light. When a pattern of light is shined on the polymer, it converts it into a solid that is then slowly displaced to cure the next layer of liquid polymer. The printing technology allows the team to fabricate a stent that precisely matches desirable design characteristics.

Sun’s 3-D printing technique, known as micro continuous liquid interface production (microCLIP), has several advantages. First, it is extremely high resolution. With the ability to print features as small as 7 microns, it is perfect for printing stents, which have very fine mesh dimensions and can be smaller than 3 millimeters in diameter. Second, it has the ability to print up to 100 stents at a time, producing them faster and potentially cheaper than traditional manufacturing methods. Third, it’s fast, printing a 4-centimeter stent in a matter of minutes.

Although current stents are made with metal wire mesh, Ameer used a citric-acid based polymer previously developed in his lab. The resulting stent is flexible, biodegradable, and has inherent antioxidant properties. Drugs can also be loaded onto the polymer and slowly released at the implantation site to improve the healing process in the blood vessel wall. Ameer has previously shown that the polymer can be engineered to inhibit clot formation when applied to vascular grafts. The stent is strong and biodegradable, allowing it to exercise its mechanical function during the vessel’s initial dilation and slowly dissolve as the re-opened blood vessel recovers.

“In theory, it’s safer because the patient doesn’t have permanent foreign metal devices in the body,” Ameer said. “If, for any reason in the future, the surgeon needs to go back in to that location in the vessel, they can. There’s not a metal stent in the way.”

Current biodegradable stents are made from plastics similar to those used for sutures. They are not as strong as wire mesh and can take longer than metal stents to fully expand when deployed. To compensate for this weakness, the plastic stents are strengthened by increasing the thickness of their struts relative to that of a metal stent. Ameer’s 3-D printed stent, however, can be fabricated with the thinner profile of traditional metal wire stents, so it is more compatible with the body.

Ameer and Sun, associate professor of mechanical engineering, imagine a future process whereby the dimensions of a patient’s vessel are obtained using standard imaging techniques available at hospitals, and a stent is then printed on site to exactly fit the vessel’s dimensions, packaged, and given to the surgeon for implantation. Next, Ameer plans to investigate how long it takes for his biodegradable stent to break down and absorb into the body. His team also aims to investigate innovative stent designs to improve their long-term performance.

“Not only can we customize the stent for a patient’s blood vessels,” he said, “but we can create all new types of patient-specific medical devices that could make the outcomes of surgical procedures better than what they are today.”

Source: Northwestern University

Promising biomaterial to build better bones with 3-D printing

A Northwestern University research team has developed a 3-D printable ink that produces a synthetic bone implant that rapidly induces bone regeneration and growth. This hyperelastic “bone” material, the shape of which can be easily customized, one day could be especially useful for the treatment of bone defects in children.

Bone implantation surgery is never an easy process, but it is particularly painful and complicated for children. With both adults and children, often times bone is harvested from elsewhere in the body to replace the missing bone, which can lead to other complications and pain. Metallic implants are sometimes used, but this is not a permanent fix for growing children.

“Adults have more options when it comes to implants,” said Ramille N. Shah, who led the research. “Pediatric patients do not. If you give them a permanent implant, you have to do more surgeries in the future as they grow. They might face years of difficulty.”

Source: Northwestern University

Draper’s first neural interface in humans

Draper engineers are rapidly moving toward realizing the technology that can provide a natural sense of feeling and proprioception—the ability to process and integrate limb orientation information—to patients who have lost a limb. The implantable device can ultimately allow those with a prosthetic limb a much more intuitive, controlled user experience with their prosthetic and an improved interaction with the world around them.
This research is funded by the Defense Advanced Research Projects Agency’s (DARPA) Hand Proprioception and Touch Interfaces (HAPTIX) program. The University of Texas Southwestern (UTSW) conducted successful testing, on behalf of Draper, of the novel electrode component in animal studies. Next, they will be tested in humans as early as the fall of 2016 as part of a follow-on Phase II contract DARPA awarded Draper in April.
The electrodes of Draper’s HAPTIX system deliver electrical signals to nerves in the forearm, much the same way the human nervous system does, creating an artificial sensory feedback. Draper’s approach is unique in that the electrodes wrap around as well as directly interact with the nerves, thus allowing for more precise stimulation and a more real sense of touch for amputees. “Draper makes inherently safe systems that work, whether we’re designing an active implantable medical device or a fault-tolerant computer system for space missions,” said Dr. Philip Parks, Draper’s HAPTIX program manager.
Full story is available from Draper website.

Boston Scientific Receives CE Mark For LOTUS Edge Valve System

Boston Scientific has received CE Mark for the LOTUS Edge™ Valve System, the company’s next generation transcatheter aortic valve implantation (TAVI) technology. The LOTUS Edge valve system is indicated for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.

In comparison to the Lotus™ Valve System, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. Another differentiating feature of the LOTUS Edge valve system is the inclusion of Depth Guard™, a design element intended to reduce the need for a permanent pacemaker (PPM).

A press release is available from Boston Scientific website.