LifeTech LAA Closure System gets CE approval

LifeTech received CE Mark approval for its LAmbre left atrial appendage (LAA) closure system , on 15 June 2016. This is the first CE marked LAA closure system from China.

LAA closure is considered as an alternative to anticoagulation in atrial fibrillation patients at risk of stroke. The recent multicenter study indicated that LAA closure is superior to anticoagulation on stroke prevention, bleeding complications and mortality. The LAmbreTM LAA closure system was designed to close LAA percutaneously through a small 8-10 Fr sheath. The main design of the device consists of a distal umbrella and a proximal cover disc connected by a short sleeve.

LAmbreTM LAA closure device is fully recapturable and repositionable. It is safe with its patented anchor design to ensure the stability of the device in LAA. It is also easy to learn and use for physicians. Dr. David Zhang, CTO of LifeTech said ” The device can be easily implanted regardless of LAA anatomy. No device embolization was observed in our clinical trials.”

Currently, only few LAA closure devices obtained CE Mark approval, including Watchman (Boston Scientific) and ACP (St. Jude Medical, acquired by Abbott). The CE mark of LAmbreTM is expected to provide more choice to physicians and patients all over the world and help increase the LAA closure acceptance in the field. LifeTech is also actively pursuing the approval of LAmbreTM LAA Closure System in China and US market.

“We are proud of the CE mark of the first LAA Closure system from China and confident that our LAmbreTM LAA closure system can compete in the global market, bringing a superior solution to both physicians and patients,” said Mr. Yuehui Xie, Chairman and CEO of LifeTech.

A press release can be found from LifeTech website by following this link.

St. Jude Medical Launches New Deep Brain Stimulation System and Directional Lead

St. Jude Medical announced the European launch of the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) System and directional DBS lead. The system, which received CE Mark approval late in 2015, will support the treatment of patients with the three most common movement disorders in the world: Parkinson’s disease, tremor and dystonia, a disorder which causes involuntary muscle contractions.

Movement disorders are neurologic conditions caused by a communication breakdown throughout the central nervous system that can result in a debilitating loss of muscle control, involuntary movement and reduced coordination. There are currently no proven cures for movement disorders, which means treatment options focus on alleviating symptoms to improve quality of life. St. Jude Medical designed the Infinity system to improve the experience of patients who rely on DBS therapy to manage their symptoms. The company also developed the St. Jude Medical directional lead to help physicians more accurately tailor DBS therapy to their patient’s specific needs while reducing side effects.

The first physician to implant the new Infinity system and the St. Jude Medical directional lead was Prof. Jan Vesper, a professor of functional neurosurgery and stereotaxy at the University Hospital in Düsseldorf, Germany, and president of the German Neuromodulation Society.

“The Infinity system is the first DBS system I’ve encountered that adjusts to the patient’s individual needs, rather than forcing the patient to adjust to the system,” said Prof. Vesper. “Offering my patients a DBS system with exceptional ease of use and smooth manageability is an exciting step in the treatment of debilitating movement disorders.”

A DBS system, like the St. Jude Medical Infinity DBS system, delivers mild electrical pulses to specific targets in the brain to stimulate the structures involved in motor control. With the launch of the Infinity system, St. Jude Medical aims to empower physicians to more accurately deliver stimulation with a DBS system. The new St. Jude Medical directional lead can deliver stimulation more precisely through eight independent electrodes that allow physicians to specifically direct current to targeted structures and areas of the brain. This advance will allow physicians to tailor the therapy to a patient’s specific needs while avoiding unnecessary stimulation to areas that may create side effects.

The Infinity system also offers new, distinct patient advantages. For patient comfort, the system is available in two different sizes, offers a maintenance-free and long-lasting recharge-free system, and uses Bluetooth® wireless technology and Apple™ digital devices for its patient controller and physician programmers. In addition, the St. Jude Medical Infinity system is also upgradeable, which provides patients the potential to access new therapy advances as they’re approved without the need for repeat surgery.

“The Infinity DBS system and directional lead design was designed to meet the needs of physicians who confirmed that they needed a system that prioritized improved stimulation targeting, device longevity and improved patient ease of use,” said Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The Infinity DBS system is our answer for these previously unmet needs, demonstrating St. Jude Medical’s commitment to patient-centric solutions that help alleviate the debilitating effects of movement disorders.”

A press release can be found from St. Jude website.

Biotronik Smallest MR Conditional Pacing Lead Available in the United States

Biotronik announced the commercial launch of Solia S ProMRI®, with a 5.6 French lead body, the smallest MR conditional pacing lead available in the United States. Solia S ProMRI is available in 45, 53 and 60 centimeter lengths.

   

Solia received Food and Drug Administration (FDA) approval on June 9, 2016 based on data collected during the Pre-Market Study (IDE) phase of the SIELLO clinical study. All Pre-Market Study primary safety and efficacy endpoints were met with statistical significance:
Primary endpoint one: 100 percent 12-month event-free rate for patients with an atrial Solia lead
Primary endpoint two: 99.6 percent 12-month adverse event-free rate for patients with a ventricular Solia lead
Primary endpoint three: 100 percent rate of successful sensing and pacing at 12 months for patients with one or two
Solia leads

The SIELLO clinical study enrolled 1,758 patients at 60 US sites with 3,220 implanted Solia leads.

“BIOTRONIK has a long-standing history of providing reliable leads without recall. Nearly 600,000 BIOTRONIK leads of this product family have been implanted worldwide. We’ve built a reputation that physicians can trust,” said Marlou Janssen, President, BIOTRONIK, Inc. “We invest significantly in innovation, but never at the expense of safety or reliability. BIOTRONIK enrolls more patients in lead studies than any other global CRM device company. We make this investment because physicians and patients deserve that level of confidence.”

With a polyurethane coating over silicone designed to reduce friction, Solia enables easier introduction through small vessels and complex anatomy. Solia’s soft distal segment is designed to help reduce stress and minimize myocardial trauma.

“Because there is a wide range of patient anatomy types, it is necessary to have various lead lengths to ensure the best outcomes. There have been, however, limitations in the variety of leads available, so this new technology will offer a more versatile lead and improve procedures,” said Ulrika Birgersdotter-Green, MD, director of pacemaker and ICD services at UC San Diego Health and professor of medicine at University of California, San Diego School of Medicine.

A press release can be found from Biotronik website.

Bioactive Film Improves How Implants Bond With Bone in Animal Study

Researchers have developed a technique for coating polymer implants with a bioactive film that significantly increases bonding between the implant and surrounding bone in an animal model. The advance could significantly improve the success rate of such implants, which are often used in spinal surgeries. The work was done by researchers at North Carolina State University, the University of Cambridge and the University of Texas at San Antonio.

The polymer in question is called polyether ether ketone, or PEEK, which has mechanical properties similar to bone, making it attractive for use in spinal implants. However, PEEK doesn’t bond well with bone. To that end, researchers had previously developed a technique for coating PEEK with a substance called hydroxyapatite (HA), which is a calcium phosphate that bonds well with bone. Proof-of-concept studies were promising, but researchers were then only able to apply the HA coating to flat surfaces and had not tested HA-coated implants in an animal model.

“We can now use our technique to coat the entire surface of an implant, and testing HA-coated implants in an animal model has given us very promising results,” says Afsaneh Rabiei, a professor of mechanical and aerospace engineering at NC State and corresponding author of a paper on the work.

The first step of the HA-coating technique – which was developed in Rabiei’s lab – coats a PEEK implant with a thin film of yttria-stabilized zirconia (YSZ). The second step applies a coating of HA. The researchers then heat the HA layer using microwaves. The YSZ layer acts as a heat shield, preventing the PEEK from melting. Meanwhile, the heat gives the HA a crystalline structure that makes it more stable in the body, meaning that the calcium phosphate will dissolve more slowly – promoting bonding with surrounding bone.

In their new study, researchers tested three types of PEEK implants in a rabbit model: PEEK implants with no coating; PEEK implants with an HA coating treated only with microwaves; and PEEK implants with an HA coating treated with both microwaves and brief exposure to an autoclave in order to enhance the HA’s crystalline structure.

The researchers used microscopic evaluations of tissue cells and three-dimensional X-ray imaging to assess the performance of all three types of implants. Eighteen weeks after surgery, the researchers found that both types of HA-coated implants had more than double the bone formation of PEEK alone, with comparable bone density. The HA-treated implants also had higher bone-to-implant contact ratios than PEEK alone.

“These results indicated an improved implant fixation in the body, decreasing the chances of loosening of the implant after surgery and the need for revision surgery to remove and replace the implant,” Rabiei says. “This improvement is due to increased regenerated bone volume around coated implants compared to uncoated PEEK.”

The researchers also did biomechanical testing on the implants, assessing their “toughness,” or how well the implant bonded to the surrounding bone.

Full story can be found from NCSU website.

Philips expands its Digital Pathology Solutions portfolio with the acquisition of PathXL

Royal Philips announced that it has acquired PathXL, a Northern Ireland-based leader in digital pathology image analysis, workflow software and educational tools. PathXL’s image analysis and tissue pathology software will complement Philips’ Digital Pathology Solutions offering, and help expand the business’ leadership in this fast-growing field. Financial details of the transaction were not disclosed.

Pathology involves the examination of patient tissue samples and plays a crucial role in the diagnosis and treatment of a wide variety of diseases, including cancer. Philips is a pioneer and leader in the digitization of pathology, a fast-growing area in healthcare as pathology labs are under pressure to improve throughput and efficiency, enhance quality and to deliver new diagnostic tests for precision medicine.

“With this acquisition, we are accelerating our drive to support global medical institutions in their transition to digitized pathology workflows,” said Russ Granzow, General Manager of Philips Digital Pathology Solutions. “Together with PathXL we see a unique opportunity to amplify our combined technology leadership positions. We will be able to offer an intelligent and integrated solution that fulfills many needs in computational pathology, education, workflow solutions and image analytics. These important and growing disciplines within pathology will enable a high-quality quantitative analysis of digital whole slide images.”

Digital pathology will enable pathologists to review and share large sets of clinical data using image analytics with the aim to help improve the quality of diagnosis and has the potential to enable new therapies and ultimately improve patient outcomes. Philips’ lntelliSite Pathology Solution* is an automated digital pathology image creation, management and viewing system comprised of an ultra-fast pathology slide scanner, an image management system and dedicated software tools.

PathXL, founded in 2004 and headquartered in Belfast, Northern Ireland, offers a range of digital pathology software applications to research and education segments of pathology and bio-pharma markets. The company has approximately 30 employees, offices in the UK and USA and distributors across three continents.

A press release can be found from Philips website.

The First Clinically Proven Bioresorbable Magnesium Scaffold Receives CE Mark

BIOTRONIK announced that the Magmaris bioresorbable scaffold has received CE mark approval. The first clinically proven magnesium scaffold, Magmaris grants physicians a new option for treating coronary artery disease without leaving a permanent implant behind. Positive data regarding the device’s safety and clinical performance from the BIOSOLVE-II trial was previously published in The Lancet; one-year data confirming long-term safety was recently published in The European Heart Journal.

“Now that clinical results have firmly established the safety and clinical performance of Magmaris, the magnesium-based scaffold could emerge as a strong alternative to currently available polymer-based scaffolds,” commented BIOSOLVE-II principal investigator Dr. Michael Haude of the Lukaskrankenhaus, Neuss, Germany. “Because it is made of magnesium, the scaffold has some unique advantages over polymer-based options in terms of deliverability and radial resistance following the implantation procedure.”

Bench tests show that Magmaris is superior to a leading polymer-based scaffold in terms of deliverability, as it requires 40 percent less force to enter and cross a lesion.1 Physicians will find it easier to steer through vascular anatomy, as 34 percent more force is transmitted to the delivery system end.1 Additionally, Magmaris’s magnesium backbone minimizes recoil following the procedure, meaning that the scaffold is able to withstand external force within the vessel. This ensures the vessel remains open following implantation to prevent potential complications.

In addition to these properties, Magmaris offers a faster resorption compared to polymer-based scaffolds. “The body’s ability to quickly resorb magnesium leads to a faster and therefore more desirable resorption time,” stated
Dr. Stephan Kische, Vivantes Cardiology Clinic, Berlin, Germany. “As the results of BIOSOLVE-II demonstrate, vessels can restore vasomotion as soon as six months after the procedure.”2

“CE mark approval for Magmaris opens a new horizon in the vascular therapeutic field,” said Dr. Daniel Buehler, President, Vascular Intervention at BIOTRONIK. “We are eager to bring our magnesium scaffold to market, as we strongly believe that only a resorbable metal alloy can provide patients the distinctive advantages capable of addressing their future needs.”

More information can be found from Biotronik website.