CE Mark Granted to Expandable, Biodegradable Biliary Stent

QualiMed Innovative Medizinprodukte GmbH, a wholly owned subsidiary of Dublin, Ireland-based Q3 Medical Devices Limited (Q3), has received CE mark approval for a dedicated percutaneous biodegradable metal alloy based stent implant for biliary applications, the UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent (BEBS).
 
The UNITY-B Percutaneous BEBS was developed for the percutaneous treatment of hepatobiliary obstruction requiring large opening drainage with the added benefit of eliminating removal procedures associated with traditional non-degradable implants. Before the recent introductions of biodegradable biliary and pancreatic drainage devices, biliary and pancreatic duct implants were made of non-degrading plastics or metals. These traditional plastic and metal implants typically require multiple procedures to place the stents, treat associated complications, and remove the implants as their removal is mandatory in most cases. The removal requirement associated with the traditional implants has the effect of doubling the total cost of care by requiring two operations (one for the device implant and one for the device removal) versus one operation (one for the device implant) for the biodegradable devices. Biodegradable devices have the added benefit of dissolving in the body after they have completed their work.

“The CE mark approval of the UNITY-B Percutaneous Biodegradable implant represents yet another milestone for QualiMed and all the companies of Q3 Medical and our collective mission of Creating Value By Helping People. In these uncertain times, being able to provide total cost of care cost-saving using advanced, clinically proven products is more important than ever,” said Eric K. Mangiardi, CEO of Q3. “As we continue the development of additional biodegradable technologies to expand our portfolio for use in the gastrointestinal tract and peripheral vasculature, we are striving to shift the paradigm for treatments by reducing complications and eliminating the need for additional removal procedures or latent complications associated with the current treatment options.” 
 
The UNITY-B biodegradable stent is a large diameter balloon expandable biodegradable implant that is introduced percutaneously and is intended to facilitate the drainage of obstructed ducts requiring larger openings. The UNITY-B biodegradable stent is designed to replace the estimated 1 billion euros-plus global market for non-degradable metal biliary implants. The UNITY-B biodegradable percutaneous stent was developed as an alternative to avoid the second removal procedures required with the traditional covered and uncovered metallic stents. The QualiMed percutaneous biodegradable balloon expandable implant provides an advanced treatment option to the traditional plastic and metallic implants used by gastroenterologists, surgeons, and interventional radiologists to reduce the total cost of care and complications associated with the older generation of non-biodegradable plastic and metallic implants. 
 
The UNITY-B Biodegradable Stent is designed based on the functionality of the musculoskeletal system where the biodegradable magnesium alloy mimics the bone and the polymer acts more like the muscle. The skeletal (magnesium) portion of the system serves as the main support structure. The muscle (polymer) helps to support movement and stability eliminating the short comings found in first-generation biodegradable technology. 

“This device opens a new era in biodegradable advancements that are easy to use and similar to the current technology so no additional training is needed. The technology also has the additional benefit of potentially eliminating the second procedure required for stent removal with the traditional technology and eliminating the cost of care for the patients and the insurance providers. With its reliable degradation profile, ease of use, and cost saving benefits the device will surely see utility in other applications throughout the gastrointestinal and peripheral vasculature,” said professor of Radiology Gianpaolo Carrafiello, from the University of Milano in Milano, Italy.
 
In a recent safety and efficacy clinical study conducted, the UNITY-B biodegradable system showed no adverse events and no serious adverse events reported as related or even possibly related to the UNITY-B study device. The final clinical success evaluation resulted to a success rate of 94.4 percent, which is outstanding in comparison to the ESGE 2012 guideline for traditional products, which just for stent dysfunction already reports 41 percent, 27 percent, and 20 percent failure rate for plastic stents, uncovered SEMS (self-expandable metallic stents) and covered SEMS, respectively.
 
Doctor Pérez-Cuadrado-Robles, an interventionalist stated, “The UNITY-B Biodegradable Stent will become a new paradigm in the management of pancreatobiliary diseases. Patients with a variety of indications, such as benign biliary strictures, biliary stones, prevention of post-sphincterotomy bleeding, biliary leaks etc. can be candidates to this technology. Indeed, this intuitive and outstanding stent can prevent second-look procedures and their procedure-related complications, resulting in a cost-effective and safe approach. Notably, the UNITY-B has major advantages in patients with a difficult access to the biliary duct (i.e., surgical anatomy). For all these reasons, this new technology should be an integral part in the management of pancreatobiliary diseases armamentarium.”
 
It is an exciting time for the company stated Eric Mangiardi, CEO of Q3 Medical as “this is only the beginning of the creative journey developing biodegradable implants for use by interventionalists and surgeons in the gastrointestinal tract as a first step and in the vasculature as a second step. The company plans to continue its development for a variety of vascular indications including the commercialization of a specialty biodegradable implants for vascular dissections and occlusions including biodegradable covered versions of the UNITY Platform. To date, Q3 Medical through its portfolio companies like QualiMed, AMG, Qsan, and QualiMed USA, has five differentiated biodegradableproducts CE approved for treatment of a wide range of gastrointestinal indications in the hepatobiliary tract. The companies are focused on additional developments to expand the biodegradable product offering in the gastrointestinal and peripheral vascular areas.”
 
QualiMed was founded in 1997 as an OEM manufacturer for implantable medical devices with a focus on the development and regulatory approval of coronary stents and their respective delivery devices. Later the business was expanded to peripheral vascular and non-vascular implants. Recently QualiMed has begun developing various biodegradable technologies, drug device combination products, and micro-intervention implants as part of its diversification and competitiveness strategy.
 
To date QualiMed has obtained CE approvals for more than 70 different products. QualiMed has developed more than four drug-eluting stents, of which it has two CE mark approvals utilizing biostable polymers and one more based on proprietary, fast-degrading, biodegradable polymer coatings entering the commercialization phase.
 
Manufacturing is organized outside of Hamburg, Germany, in the town of Winsen, where QualiMed runs two Class 10,000 cleanrooms according to EEC GMP standards. The company has production capabilities for stents, catheters, drug device combination products, and biodegradable technologies for a variety of interventional and surgical applications.
 
Q3 Medical Devices Ltd. is an Ireland based holding company with multiple global operations in Germany, China, and the United States along with strong global partnerships and an ever growing strategic investor base. The holding and its companies develop, manufacture, and distribute bioresorbable, micro invasive, localized intraluminal drug delivery, and core products platforms for interventional cardiology, peripheral vascular, and non-vascular diseases.
 
Q3 Medical Devices Ltd. was formed by a global group of entrepreneurs, manufactures, industry doctors, and investors, focused on the development and acquisition of medical device businesses with annual revenues between $1 million and $10 million. The acquisitions are targeted in areas that expand the groups manufacturing base and capabilities, grow its distribution channel, and accelerate its products offering, focusing on the minimally invasive treatment of patients with cardiology, peripheral vascular and non-vascular diseases.