Edwards Found to Infringe on Boston Scientific Patents in Germany and U.K.

Boston Scientific announced the German District Court of Düsseldorf has determined that Edwards Lifesciences Corporation and its German subsidiary’s Sapien 3™ device infringed two patents of Boston Scientific Scimed, Inc. related to the seals for transcatheter heart valves, specifically the German parts of EP 2 749 254 B1 and EP 2 926 766 B1.

The Lotus™ Valve System is designed 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. The Lotus Valve Adaptive Seal™ is a technology that creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality.

Boston Scientific and its German subsidiary were also found not to infringe upon Edwards’ German part of EP 1 441 672 B1, but to infringe upon Edwards’ German part of EP 2 399 550 B1; however, the company believes that the ‘550 patent will be revoked by the European Patent Office (EPO).

Edwards Lifesciences and Boston Scientific can appeal each of the four decisions as far as the District Court of Düsseldorf has decided against them. Each company has opposed the other’s patents in the EPO.

This decision in Germany follows the March 3, 2017, ruling from the Patents Court of the High Court of Justice in England, which also ruled in favor of Boston Scientific Scimed, Inc., finding that Edwards’ Sapien 3 device infringes Boston Scientific patent EP (UK) 2 926 766 and that all claims of that patent were valid. Edwards has stated that it will seek permission to appeal this judgment.

“We will continue to protect our intellectual property to ensure we can continue to bring forward innovative technologies that make a meaningful difference in the lives of patients,” said Tim Pratt, executive vice president, chief administrative officer, general counsel and secretary, Boston Scientific. “We are pleased with the progress we are making with litigation in Europe, and believe the strength of our intellectual property will also be upheld in U.S. cases involving the same patents.”

The Lotus Valve is currently not available for use or sale.

Source: Boston Scientific

Denttio warned by FDA for violating MDR procedures

FDA issued warning letter to Denttio Inc, in which FDA cited 12 violations to regulations. These regulations include but not limited to

1.    Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
2.    Failure to establish procedures for corrective and preventive action as required by 21 CFR 820.100(a).
3.    Failure to establish a design history file as required by 21 CFR 820.30(j).
4.    Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g).
5.    Failure to maintain device master records as required by 21 CFR 820.181.
6.    Failure to establish procedures for finished device and incoming product acceptance as required by 21 CFR 820.80.
7.    Failure to establish Device History Record procedures as required by 21 CFR 820.184.
8.    Failure to adequately establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a).
9.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system as required by 21 CFR 820.20(c).
10.    Failure to perform quality audits as required by 21 CFR 820.22.
11.    Failure to adequately establish procedures for training and identify training needs as required by 21 CFR 820.25(b).
12.    Failure to establish document control procedures as required by 21 CFR 820.40 (a).
The warning letter is available on FDA website.

Velano Needle-Free Blood Draw Technology FDA Approved

Photo: Velano Vascular

Medical device innovator Velano Vascular announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its innovative needle-free vascular access device that seeks to improve the blood draw experience for patients while reducing risk to both patients and practitioners. Based on significant usage and input from practitioners, the new, improved device is designed for ease-of-use and high volume manufacturing.

“The deliberate and thoughtful design inputs for the next generation of PIVO reflect our commitment to rapid product development cycles informed by real world experience in the country’s leading health systems,” said Velano Vascular Chief Executive Eric M. Stone. “Feedback from hundreds of practitioners already using our technology reinforced PIVO’s ability to enhance the blood draw experience for patients and clinical staff, and helped us to develop a next generation product better suited for widespread adoption.”

PIVO is a single-use, disposable device that enables consistent, high quality blood samples from indwelling peripheral IV lines, allowing hospitals to reduce reliance on repeated needle sticks and central line access for blood collection. In addition to seeking a more compassionate care experience for patients, a safer environment for practitioners, and a more financially responsible alternative for health systems, PIVO aims to equip hospitals to better serve the increasing population of DVA (Difficult Venous Access) patients.

“Our experience with PIVO illuminates that blood draws can be a painless, lower risk experience for patients and practitioners,” explained Sutter Health Chief Nurse Officer Anna Kiger, DNP, D.Sc., MBA, R.N. “By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care.”

PIVO is currently in use at multiple health systems nationwide and will be available more broadly in 2017 following this FDA-clearance for the second generation PIVO solution. Frost & Sullivan awarded PIVO its New Product Innovation Award for Vascular Access in 2016.

Source: Velano Vascular

FDA approves Abbott’s sensor-enabled flexible ablation catheter

Picture: Abbott

Abbott announced U.S. Food and Drug Administration (FDA) approval of the FlexAbility™ Ablation Catheter, Sensor Enabled™ designed to improve the versatility and precision during cardiac ablation procedures to treat atrial flutter, a type of irregular heartbeat. With the approval, the company has further expanded its electrophysiology portfolio for treating patients struggling with abnormal heart rhythms (cardiac arrhythmias).

The FlexAbility™ Ablation Catheter, Sensor Enabled™ is the first ablation catheter from Abbott that helps collect both electrical current resistance (impedance) and magnetic data to facilitate detailed, accurate mapping as well as assist in the treatment of sites that trigger or sustain abnormal heart rhythms. It also represents the second Sensor Enabled™ tool released by Abbott in the United States for the use with the company’s EnSite Precision™ cardiac mapping system, which also includes the Advisor™ FL Circular Mapping Catheter, Sensor Enabled™.

When used with the EnSite Precision™ cardiac mapping system, Sensor Enabled™ catheters allow physicians to create highly detailed 3-D cardiac models with the heart’s electrical activity overlaid on it. These models help the physicians identify the type of arrhythmia and the areas they should treat with the ablation catheter.

The catheter is also compatible with Abbott’s MediGuide™ Technology, which allows the physician to reduce the duration of live X-ray during a procedure.

“I am seeing an increasing number of patients with complex cardiac arrhythmias, which has created a strong need for advanced tools that can meet the needs of those patients” said Jeffrey Winterfield, M.D., director, Ventricular Arrhythmia Service and associate professor of cardiac electrophysiology at the Medical University of South Carolina. “Sensor Enabled™ catheters, along with EnSite Precision™ cardiac mapping system, allow me to quickly identify and treat the arrhythmia, giving me the flexibility and accuracy I need to reach the most challenging locations in the heart to support effective outcomes and improve the lives of my patients.”

The FlexAbility™ Ablation Catheter, Sensor Enabled™ is based on the original FlexAbility™ ablation catheter platform, which featured the first irrigated flexible tip providing directed flow and tip temperature monitoring aimed at reducing procedural risk. The new enhanced FlexAbility™ Ablation Catheter, Sensor Enabled™ adds the ability to collect magnetic data, providing procedural versatility and precision when integrated with Abbott mapping and navigation systems.

“We are continuing to innovate around the EnSite Precision™ cardiac mapping system to create an ablation portfolio that best supports physicians looking to tackle even the toughest cases,” said Srijoy Mahapatra, M.D., medical director of Abbott’s electrophysiology business. “The introduction of the sensor enabled ablation catheter is delivering on that need. It offers the ability to engage the magnetic platform for enhanced precision, especially when physicians encounter a complex case.”

Source: Abbott

How Cancer Cells May Develop Resistance to FGFR Inhibitors

A new study by researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) has identified a mechanism by which cancer cells develop resistance to a class of drugs called fibroblast growth factor receptor (FGFR) inhibitors.

The study, published in the journal Molecular Cancer Therapeutics, also found that use of a second inhibitor might improve the effectiveness of these drugs by possibly preventing resistance, and it recommends that clinical trials should be designed to include a second inhibitor.

FGFR inhibitors are a new family of targeted agents designed to inhibit the action of the fibroblast growth factor receptor, which is often overexpressed in lung, bladder, biliary and breast cancers.

“Understanding how drug resistance develops can help in the design of new agents or strategies to overcome resistance,” says principal investigator Sameek Roychowdhury, MD, PhD, assistant professor of medicine and of pharmacology in the Division of Medical Oncology at the OSUCCC – James.

“Our paper demonstrates in a laboratory model how cancer can evade this class of therapy, and it provides insights into how clinical trials for these therapies could be further developed to overcome the problem of drug resistance,” he adds.

The laboratory study by Roychowdhury and his colleagues induced resistance to the FGFR inhibitor BGJ398 in lung- and bladder-cancer cells after long-term exposure to the agent. The researchers then found that, while the drug continued to inhibit FGFR activity in the resistant cells, its inhibition of FGFR signaling had no appreciable effect on the cells’ survival.

Examining other molecules in the FGFR pathway, the researchers found that a regulatory protein called Akt remained highly active, even during FGFR inhibition. Akt, a key regulator of cell biology, is directly involved in cell proliferation, cell survival and cell growth.

Furthermore, they found that by inhibiting Akt they could significantly slow cell proliferation, cell migration and cell invasion in the lung cancer and bladder cancer cells.

“Fibroblast growth factor receptor inhibitors are new therapies being developed in clinical trials for patients whose cancer cells have genetic alterations in this family of genes,” says Roychowdhury, a member of the OSUCCC – James Translational Therapeutics Program. “We believe our findings will help improve this therapy for lung, bladder and other cancers.”

Source: OSUCCC – James

How 3D printing could save lives

Photo: University of California San Diego

In the past decade, engineers at the University of California San Diego have 3D printed a variety of devices ranging from rocket engines, to robots, to structures inspired by the seahorse’s tail. Now, nanoengineers have added a new item to that list: a 3D printed biomimetic blood vessel network.

The new research, led by nanoengineering professor Shaochen Chen, addresses one of the biggest challenges in tissue engineering: creating lifelike tissues and organs with functioning vasculature — networks of blood vessels that can transport blood, nutrients, waste and other biological materials — and do so safely when implanted inside the body.

Researchers from other labs have used different 3D printing technologies to create artificial blood vessels. But existing technologies are slow, costly and mainly produce simple structures, such as a single blood vessel — a tube, basically. These blood vessels also are not capable of integrating with the body’s own vascular system.

“Almost all tissues and organs need blood vessels to survive and work properly. This is a big bottleneck in making organ transplants, which are in high demand but in short supply,” said Chen, who leads the Nanobiomaterials, Bioprinting, and Tissue Engineering Lab at UC San Diego. “3D bioprinting organs can help bridge this gap, and our lab has taken a big step toward that goal.”

Chen’s lab has 3D printed a vasculature network that can safely integrate with the body’s own network to circulate blood. These blood vessels branch out into many series of smaller vessels, similar to the blood vessel structures found in the body.

Chen’s team developed an innovative bioprinting technology, using their own homemade 3D printers, to rapidly produce intricate 3D microstructures that mimic the sophisticated designs and functions of biological tissues. Chen’s lab has used this technology in the past to create liver tissue and microscopic fish that can swim in the body to detect and remove toxins.

Researchers first create a 3D model of the biological structure on a computer. The computer then transfers 2D snapshots of the model to millions of microscopic-sized mirrors, which are each digitally controlled to project patterns of UV light in the form of these snapshots. The UV patterns are shined onto a solution containing live cells and light-sensitive polymers that solidify upon exposure to UV light. The structure is rapidly printed one layer at a time, in a continuous fashion, creating a 3D solid polymer scaffold encapsulating live cells that will grow and become biological tissue.

“We can directly print detailed microvasculature structures in extremely high resolution. Other 3D printing technologies produce the equivalent of ‘pixelated’ structures in comparison and usually require sacrificial materials and additional steps to create the vessels,” said Wei Zhu, a postdoctoral scholar in Chen’s lab and a lead researcher on the project.

And this entire process takes just a few seconds — a vast improvement over competing bioprinting methods, which normally take hours just to print simple structures. The process also uses materials that are inexpensive and biocompatible.

Chen’s team used medical imaging to create a digital pattern of a blood vessel network found in the body. Using their technology, they printed a structure containing endothelial cells, which are cells that form the inner lining of blood vessels.

The entire structure fits onto a small area measuring 4 millimeters × 5 millimeters, 600 micrometers thick (as thick as a stack containing 12 strands of human hair).

Reearchers cultured several structures in vitro for one day, then grafted the resulting tissues into skin wounds of mice. After two weeks, the researchers examined the implants and found that they had successfully grown into and merged with the host blood vessel network, allowing blood to circulate normally.

Chen noted that the implanted blood vessels are not yet capable of other functions, such as transporting nutrients and waste. “We still have a lot of work to do to improve these materials. This is a promising step toward the future of tissue regeneration and repair,” he said.

Moving forward, Chen and his team are working on building patient-specific tissues using human induced pluripotent stem cells, which would prevent transplants from being attacked by a patient’s immune system. And since these cells are derived from a patient’s skin cells, researchers won’t need to extract any cells from inside the body to build new tissue. The team’s ultimate goal is to move their work to clinical trials. “It will take at least several years before we reach that goal,” Chen said.

Source: University of California San Diego