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.

FDA Approved Tryton Side Branch Stent for Coronary Bifurcation Lesions

Picture: Tryton Medical

Tryton Medical, Inc. announced the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) application for the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions involving large side branches (appropriate for a ≥2.5mm stent). The Tryton Side Branch Stent is the first dedicated bifurcation device to receive regulatory approval in the U.S.

Coronary artery disease (CAD), the leading cause of death in the U.S. in both men and women, often results in the buildup of plaque at a site where one artery branches from another, also known as a bifurcation. Approximately 20-30% of all patients undergoing percutaneous coronary interventions (PCI) to open blocked arteries have a bifurcation lesion. Provisional stenting of the main branch is the current standard of care, but in many cases the side branch is not stented, leaving it vulnerable to complications like occlusion requiring bailout stenting.

“It is estimated that nearly a third of all patients treated with angioplasty each year have a bifurcation lesion, and the standard provisional treatment approach leads to side branch occlusion and bailout stenting far too often,” said Shawn McCarthy, President and CEO of Tryton Medical. “With this first-of-its-kind approval in the U.S., interventional cardiologists now have access to a stent that is specifically engineered to provide the complete lesion coverage and more predictable patient outcomes needed for the challenging anatomy of coronary bifurcation lesions.”

In a post hoc analysis of a randomized investigational device exemption (IDE) clinical trial, treatment with the Tryton Side Branch Stent in the intended population of patients with large side branches (appropriate for a ≥2.5mm stent) reduced the need for additional bailout stenting (0.7% vs. 5.6%, P = 0.02) and led to statistically significant lower side branch percent diameter stenosis at nine month follow up (30.4% vs. 40.6%, P = 0.004) when compared to provisional stenting. The post hoc analysis also showed comparable major adverse cardiovascular events (MACE) and myocardial infarction (MI) rates versus provisional stenting at three years.

The safety profile of the Tryton Side Branch Stent was validated in a confirmatory study that compared patients treated with the Tryton stent to a performance goal based on performance of the control arm from the randomized IDE clinical trial. The confirmatory study met its pre-specified primary endpoint, periprocedural myocardial infarction (PPMI), which was within its non-inferiority margin (Primary Endpoint: 10.5% + 95% C.I. vs. 17.9%, p=0.01).

“Treatment of complex lesions at the site of a bifurcation has historically been inconsistent, with results varying depending on the procedure and the experience of the interventionist,” said Aaron Kaplan, MD, Professor of Medicine at Dartmouth Hitchcock Medical Center and Chief Medical Officer of Tryton Medical. “A predictable bifurcation solution helps alleviate some of the stress in these procedures by limiting variability and reducing the need for bailout stenting. This important FDA decision could have a profound impact on treatment protocols and guidelines for significant bifurcation lesions in the years ahead.”

Tryton has signed a strategic distribution agreement with Cardinal Health enabling Cordis, its interventional vascular business, to be the exclusive distributor of the Tryton Side Branch Stent in the U.S. “This strategic agreement is a significant step for Cordis to quickly get innovative technologies into the hands of our customers in the U.S. We are actively preparing to commercially launch this product with Tryton to ensure physicians will soon have a new treatment option in their cath labs to help deliver the best patient care available,” said David Wilson, President of Cordis.

The Tryton Side Branch Stent is available in multiple device diameters (2.5mm to 3.5mm in the side branch) and is compatible with any conventional drug eluting stent in the main vessel.

Source: Tryton Medical

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

FDA approves CyPass Micro-Stent

The CyPass® Micro-Stent is a minimally invasive device that can be implanted at the time of cataract surgery. About 20% of patients undergoing cataract surgery also have glaucoma, leading to a large number of patients who could conveniently receive combined therapy.

FDA has approved CyPass micro stent from Alcon Laboratories.

Product Name: CyPass® System Model 241-S
PMA Applicant: Alcon Laboratories, Inc.
Address: 6201 South Freeway, Fort Worth, TX 76134-2099
Approval Date: July 29, 2016
Approval Letter: Not Yet Available
What is it? The CyPass® Micro-Stent is a tiny tube that is implanted into the eye to help drain fluid that builds up in patients with glaucoma. The CyPass® System consists of a small stent (CyPass® Micro-Stent) that is pre-loaded into a stent delivery tool (CyPass® Applier).
How does it work? The CyPass® Micro-Stent is designed to control eye pressure (intraocular pressure, or IOP) by creating a drainage pathway from the inside (anterior chamber) to the outermost layer of the eye (suprachoroidal space).
When is it used? The CyPass® Micro-Stent is used in patients with primary open angle glaucoma (POAG). If not treated, pressure builds up inside the eye and eventually can damage the optic nerve, causing blindness. The CyPass® Micro-Stent is placed in the eye at the time of cataract surgery.
What will it accomplish? Data supporting the approval of this device included 374 subjects implanted with the CyPass® Micro-Stent device at the same time as cataract surgery, and 131 patients that had cataract surgery alone. In this study, 72.5 percent of patients who received the CyPass® Micro-Stent achieved a significant lowering of their IOP compared to 58 percent of patients who had cataract surgery alone. The lower IOP lasted through the 2-year-long study. Complications occurred in 39.3 percent of patients with CyPass® Micro-Stent and cataract surgery and in 35.9 percent of patients with cataract surgery alone.
When should it not be used? The CyPass® Micro-Stent should not be used if:

  • patients have a type of glaucoma other than POAG.
  • eye anatomy or condition is unusual.
Product information can be found from Transcend Medical website.
FDA announcement can be found from FDA website.

Chinese manufacturer launches stent product

In China, number of stent implantation already reached as high as 840.000 cases per year in 2012, but Chinese medical device producers just could not produce any stent product due to the limitation of material and technics.

A team of scientists had actually kicked off the R&D of stent ever since 1999, only until early 2015 had the team developed prototype product. The product had got CFDA clearance by the nd of 2015 and it is available in the market since January 2016. This is the first stent ‘Made in China’, after more than 15 years of development.

Almost at the same time, CFDA approved a implants made from degradable metal, which was developed by the same team.