BB&T European Editor and Staff Reports

PARIS — Europe is back on the frontlines in the development of transcatheter aortic valve implantation (TAVI).

Two next-generation devices for TAVI were launched last month at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; Freiburg, Germany) in Lisbon by Symetis (Lausanne, Switzerland) and JenaValve (Munich).

Both devices offer distinctive features from the first generation products approved for use in Europe, the Sapien line from Edwards Lifesciences (Irvine, California) and CoreValve from Medtronic (Minneapolis).

Especially significant is that both next generation valves use the transapical approach between two ribs that requires a surgeon, rather than the transfemoral access used primarily by interventional cardiologists.

Edwards now faces a strong challenge in transapical delivery where it has held an exclusivity, and which accounts for a steady share of 25% of TAVI procedures in Europe, even higher at some heart centers.

Symetis estimates the market for TAVI will exceed $2 billion by 2014.

Larry Biegelsen at Wells Fargo Securities has projected a 5% share of the European TAVI market in 2012 for Jena Valve and Symetis and a robust 10% in 2013, all of it coming from Edwards with an estimated 45% of TAVI sales in transapical.

Biegelsen notes that both challengers are also developing valves and delivery systems for the transfemoral access where Edwards and CoreValve are locked in a fierce competition for the lion's share of procedures.

The focus on transapical access promises to renew the struggle to establish 'heart teams' at implantation centers, a model that insists on collaboration between surgeons and interventional cardiologists rather than the competition and conflict that typically marks their relations.

The two new valves for transapical delivery also rekindle debate over the durability of heart valves delivered by catheters.

The larger diameter of valves placed in traditional surgery have a 20-year history of data supporting their use.

Data on TAVI valves only extends back four years and their performance is being closely watched.

Valves delivered transapically have a diameter similar to surgically placed valves where the valves for transfemoral delivery need to be crimped severely down to the 18 French diameter used to navigate the narrower arteries of the leg.

The smaller size demands a different design for the leaflets that open and close in transfemoral valves.

According to Essinger, durability of leaflets is the critical in the design of transapical valves where for transfemoral valves size becomes the determining design criteria.

Greater surgeon control key to new TAVI valves

Growth in the market for transcatheter aortic valve implantation (TAVI) looks like a steep ski hill with rapid take up at European heart centers.

Yet the two companies that introduced new aortic valves for this less-invasive alternative to traditional surgery share a go-slow strategy for rolling out their new products.

“The greatest danger we face is migrating too rapidly from a clinical study paradigm to a commercial paradigm,“ said Jacques Essinger, the CEO of Symetis.

“We have had outstanding clinical results and we must maintain the same clinical excellence before moving to commercialization,“ he said, adding, “It is a significant investment we cannot rush. So the number of centers we open in 2012 will be driven by the ability to maintain the excellence.“

JenaValve's CEO, Helmut Staubinger, expressed a similar approach. “Market share is not our goal at this point, our objective is first to establish that we have a true second-generation valve,“ he said. “We will start very slowly, very carefully with centers that are experienced in TAVI procedures and then advance step by step.“

Clinical data from the first wave of patients implanted with the Jena and Symetis valves show significant improvement for paravalvular leakage over the first-generation valves.

Both new valves also respond to calls from physicians for more flexibility in positioning the device and both report positive reactions by surgeons after trialing their respective systems.

The delivery system for the Symetis Acurate valve features a self-positioning system using a cone-shaped tip that assures more precise centering of the valve in the aortic annulus.

JenaValve's innovation in TAVI delivery are three feeler prongs that touch the cusps behind the native valve leaflets and provide a tactile feedback in the physician's hand to assure the final positioning of the valve.

The JenaValve system enables the surgeon to reposition and rotate to adjust the placement, and even to retrieve the valve back into the catheter if he is not satisfied with the placement.

The JenaClip does not require rapid pacing of the patient's heart as blood can continue to flow through the annulus during deployment.

French artificial heart passes first hurdles

Cardiac surgeons got the first look last month at results for pre-clinical testing of an implantable artificial human heart during the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS; Freiburg, Germany) in Lisbon.

This is the target audience for Carmat (Paris), which hopes to go forward with a first-in-man implantation in early 2012, and the presentation of the abstract was a first step in introducing the device to practicing surgeons.

Haemocompatibility of the Carmat Total Artificial Heart is a distinguishing feature of the device and creates a key competitive advantage in a market with a global patient population of 100,000 where the company projects a sales potential of $1 .6 billion annually.

The study confirmed the expectations of Carmat showing a limited consumption of fibrin, a limited release of reactive substances by blood platelets and minor blood cell depositions on the surfaces. The company expects to launch the artificial heart in 2013.

St. Jude neurostimulation lead launched in Japan

St. Jude Medical (St. Paul, Minnesota) reported regulatory approval from the Japanese Ministry of Health, Labor and Welfare of the Penta surgical lead for neurostimulation therapy to manage chronic pain.

The Penta surgical lead addresses complex pain patterns like low back pain and arm and leg pain. Arranged in five columns, the lead is designed to selectively stimulate nerve fibers associated with the patient's area of pain without affecting other areas. The Penta lead features a micro-texturing process that enables greater amounts of current to be delivered via the small electrodes.

The Penta surgical lead can be used with the St. Jude Medical Eon Mini spinal cord stimulator. Roughly the size of a man's watch, the Eon Mini neurostimulator's thin, small design makes it well suited for those patients whose body type requires a small device, the company said. In addition to Japan, the Penta lead is also available in the U.S., Europe, Australia and Canada.

Neurostimulation (also called spinal cord stimulation) is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. Using mild electrical pulses to interrupt or mask the pain signals as they travel to the brain, the neurostimulator can be programmed to meet each individual patient's needs.

Brainsway wins Israeli approval for Deep TMS

Brainsway (Jerusalem, Israel) has received approval from Israel's Ministry of Health to market and sell its Deep TMS (transcranial magnetic stimulation) device to four medical centers for the treatment of major depression, bipolar disorder and negative symptoms and cognitive impairment in schizophrenic patients.

Uzi Sofer, Brainsway's CEO, said, “We are very pleased to receive this vote of confidence in the Deep TMS technology from our homeland's regulatory authority. We are now working to update indications with the Israeli Ministry of Health to bring them more in line with the approvals that we've already received in Europe.“

Brainsway's Deep TMS systems are designed for treatment of a wide range of neurological and psychopathological disorders.

Cutera gets Health Canada approval for Excel V

Cutera (Brisbane, California) reported Health Canada approval for its Excel V laser, designed to provide a technological breakthrough for the most common procedures of an aesthetic dermatologist's practice – vascular, pigment, and overall skin rejuvenation treatments.

According to Cutera, the Excel V laser offers a significant advancement versus currently available lasers. At the touch of a button, and guided by built-in navigation, physicians can easily treat a broader range of vascular and pigmented indications. One ergonomic handpiece features both a 532 nm laser, optimized for superficial vessels and pigments, and a 1064 nm Nd:YAG laser to treat challenging vascular conditions, such as leg veins, port wine stains and hemangiomas (capillary abnormalities). The second handpiece, Genesis V, for facial rejuvenation, affords a gentle and collagen-producing solution for fine lines, uneven texture and premature aging without downtime, Cutera noted.

Capsule to expand connectivity offering in Europe

Capsule (Andover, Massachusetts) reported plans to expand its connectivity offering in Europe. Building on its record growth in 2010, the company is focusing on expansion in Europe through partnerships with European healthcare information systems vendors and biomedical device manufacturers.

Capsule's software and hardware products automate the charting process and improve clinical workflow by seamlessly connecting medical devices to information systems across the entire healthcare enterprise. Automation of this process recovers nursing hours, improves direct patient care time, reduces charting errors, improves decision making and increases the adoption of the EMR.

Capsule's Enterprise Medical Device Connectivity Solution includes both electronic medical software and hardware. Connectivity options are available for all areas of the hospital – from higher acuity areas (critical care, operating room) to lower acuity areas (med-surg and general wards) to mid-acuity areas (emergency). The key components, Capsule's DataCaptor Connectivity Software and the Capsule Neuron Platform, deliver a patient-centered solution that integrates with existing technologies and infrastructures while enhancing caregiver work processes.

Ansell gloves classified as Class III devices

Ansell Healthcare (Brussels, Belgium), a developer of healthcare barrier protection, reported that it has received the CE Mark for Gammex powder-free gloves with AMT Antimicrobial Technology. Through its unique virus and bacteria-killing technology, the gloves provide protection against some of the most common pathogens and drug-resistant bacteria in the event of a glove breach. Ansell will commercially launch the gloves across Europe in the autumn of 2011.

The gloves, made of natural rubber latex, provide the same feel, sensitivity, flexibility and dexterity as conventional gloves when manipulating and handling instruments. The main difference is the active antimicrobial layer which contains chlorhexidine gluconate. This technology can provide ongoing antiviral and antibacterial protection against HIV, hepatitis C and infectious bacteria, Ansell says.

Boston Sci launches Promus Element DES in China

Boston Scientific (Natick, Massachusetts) has begun a phased launch of its Promus Element everolimus-eluting platinum chromium coronary stent system in China. The launch campaign will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals. The company previously received registration approval for the Promus Element stent system from the State Food and Drug Administration of the People's Republic of China.

The product represents the company's third-generation drug-eluting stent (DES) technology, which incorporates a platinum chromium (PtCr) alloy, innovative stent design and advanced catheter delivery system. It is designed to offer greater strength, enhanced deliverability and exceptional visibility, and is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution. The advanced low-profile delivery system facilitates precise delivery of the stent across challenging lesions.

The Promus Element is being evaluated in a separate PLATINUM clinical program, which includes five multi-center studies totaling more than 1,800 patients worldwide. In April, 12-month results announced from the PLATINUM Workhorse randomized, controlled trial demonstrated the clinical non-inferiority of the PROMUS Element stent in comparison to the PROMUS stent in treating de novo coronary artery lesions while also showing a procedural benefit of reduced rates of unplanned stenting.

Capella expands network to Middle East and Asia

Cappella Medical Devices (Galway, Ireland), a device company developing solutions for the treatment of coronary bifurcation disease, reported that Doox Medica has been named as the exclusive distributor in Middle Eastern territories and the Sideguard Coronary Stent system has been approved by the Saudi FDA. The Sideguard incorporates Cappella's stent design and balloon delivery system and offers the interventional cardiologist a unique product solution for providing ostial protection and side branch preservation for a wide range of bifurcation lesions.

Cappella's Sideguard coronary sidebranch technology offers interventional cardiologists a solution that preserves the sidebranch of diseased coronary arteries by protecting the ostium while minimizing plaque shift. The Sideguard delivery system features a proprietary split-sheath, balloon released, technology that is designed to ensure precise placement on the ostial borderline. The Sideguard self-expanding, nitinol, stent promotes continuous wall apposition and positive remodelling and its unique trumpet-shaped design conforms to varying characteristics of the sidebranch ostium.

Snoasis reports Canandian distribution

Snoasis Medical (Denver) says it has obtained Canadian regulatory clearance for BioXclude, a membrane composed of allograft amnion-chorion tissue for use as a wound covering in dental surgery. BioXclude will be marketed exclusively by Citagenix (Laval, Quebec), a Canadian regenerative products company.

Amnion-chorion tissue is often referred to as the amniotic sac, the part of the placenta that encloses and protects the unborn baby through term. Amniotic tissue is considered immunoprivileged, possesses anti-bacterial and anti-microbial properties, reduces inflammation at the wound site, and provides a protein-enriched matrix to facilitate wound healing.

Snoasis develops regenerative tissue and medical device products for use in dental surgery. In 2008, Snoasis obtained the exclusive license and worldwide distribution rights to all current and future placental tissue products processed by Surgical Biologics, a MiMedx Group Company (Kennesaw, Georgia). Snoasis initiated commercial distribution of BioXclude in the U.S in March 2010.

Flexivue Microlens receives Israeli registration

Presbia (Los Angeles) said it has received medical device registration approval in Israel for its solution for near vision loss. With this approval, the Flexivue Microlens, a treatment for presbyopia that eliminates dependence on reading glasses or contact lenses for seeing near objects, is now commercially available in more than 40 countries across Europe, Latin America and the Middle East.

Presbia's Flexivue Microlens solution involves implanting a 3 mm lens, approximately 15 microns in edge thickness, in the corneal stroma of the patient's non-dominant eye. Using Presbia's proprietary insertion tool, the lens is placed in a pocket created in the cornea by a femtosecond laser. The lens may stay in place permanently, or can be removed and/or replaced if the patient's presbyopia advances and a stronger prescription is required. The less than 10-minute procedure requires no general anesthesia, and the patient's visual recovery takes only a couple of days. Since the Flexivue Microlens solution utilizes standard equipment and requires minimal additional training, the procedure requires no significant capital investment by the surgeon's practice.

Vexim obtains its registration for SpineJack in India

Vexim (Toulouse, France) said last month it has obtained the registration certificate for SpineJack in India. The SpineJack is a titanium implant (5 mm in diameter and 25 mm in length) that covers 80% of spinal column fractures (vertebrae TH10 to L5). It is inserted into a patient's vertebra via a transpedicular, minimally invasive approach (just one or two 5 mm skin incisions). A simple but specialized set of instruments is used to prepare the vertebra for the X-ray-guided insertion of one or two implants, depending on the anatomical configuration of the fracture and the degree of reconstruction required. Once this step has been completed, bone cement is injected into the restored vertebra in order to secure the vertebral structure and relieve the patient's pain. A trained surgeon needs only 25 to 35 minutes to complete the whole procedure. In July 2009, the company signed an exclusive agreement with Stryker EMEA, part of Stryker (Kalamazoo, Michigan) for distribution of the SpineJack in Germany, the UK, Austria and Ireland. SpineJack is CE marked and was first commercialized in mid-2010.