BB&T Senior Staff Writerand BB&TStaff Reports

St. Jude Medical (St. Paul, Minnesota) reported the first human implant of its Portico transcatheter aortic heart valve. John Webb, MD, director of cardiac catheterization and interventional cardiology at St. Paul's Hospital (Vancouver, British Columbia) performed the procedure.

“The first human implant of the Portico transcatheter valve is a significant milestone for our transcatheter aortic valve replacement program and was built off of our 30-year legacy in surgical heart valves,“ said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division.

Callaghan told BB&Tthe valve is designed to address several key limitations associated with the first generation of transcatheter valves. “What we've done over the last couple of years is try to understand from other projects and endeavors in the space what are the remaining clinical problems that have not been met,“ he said. One need St. Jude identified while designing the Portico valve was the ability to re-sheath (bring the valve back into the delivery catheter), reposition, or retrieve the device if necessary.

“Nobody else that we're aware of has the ability to partially deploy the valve and re-sheath it,“ Callaghan said. In other words, if a physician deploys the valve and the position is not as it should be, he is either “stuck with it as it is or has to take extraordinary measures to either drag it out of the patient or position a second valve.“

In the first in man case, performed by Webb, this ability was demonstrated as the device had to be recaptured and repositioned during its first implant procedure, Callaghan told BB&T.

The valve, which is made of bovine pericardial tissue, is designed to increase physicians' control and placement accuracy during valve deployment. St. Jude says the Portico transcatheter heart valve can be completely re-sheathed (the process of bringing the valve back into the delivery catheter) and retrieved before it is released from the delivery system, allowing physicians to reposition the valve at the implant site. No transcatheter valve currently on the market has the ability to be re-sheathed, repositioned, or retrieved, St. Jude noted.

“We think that's going to be a key point of differentiation,“ Callaghan said. He added that other design enhancements have also been built into the valve to address other limitations of first generation transcatheter valves, such as the incidence of heart block. “Certain products available today in Europe experience high incidence of heart block, so we've designed this valve to mitigate the incidence of heart block.“

This first-in-man trial will enroll 30 patients, Callaghan said, prior to the company starting its formal CE mark trial which it expects to start later this year.

St. Jude said the transcatheter heart valve was designed for the estimated 400,000 patients with severe aortic stenosis who are considered to be high risk or inoperable for conventional open-heart valve replacement therapy. Two delivery methods will be available for the Portico valve, transfemoral (delivered via the femoral artery) and transapical (delivered via a small incision in the apex of the left ventricle).

“Many of the shortcomings of first generation devices have been addressed with the next generation St. Jude Medical Portico transcatheter valve,“ said Gregory Fontana, MD, professor and vice chairman of the Department of Surgery at the Cedars-Sinai Heart Institute (Los Angeles, California).

Last year St. Jude reported that Fontana, and Raj Makkar, MD, director of the Interventional Cardiology and Cardiac Catheterization Laboratory at the Cedars-Sinai Heart Institute, will be the principal investigators in the company's transcatheter aortic valve implantation (TAVI) clinical trial. The study will evaluate the safety and efficacy of the St. Jude transcatheter aortic valve for patients who experience severe aortic stenosis and who may be at an elevated risk for open-heart surgery.

“The St. Jude Medical transcatheter valve is a promising new technology that is likely to offer increased functionality for transfemoral and transapical implantation,“ Makkar said. “We are looking forward to offering an advanced, less-invasive treatment for patients at high risk for surgery.“

Analysts continue to expect big things from the TAVI market, especially for Edwards Lifesciences (Irvine, California), which is seen as a front runner in the TAVI market. According to a Canaccord report released last fall analysts are “increasingly confident“ in their long-term TAVI market expectations and its specific long-term expectations for Edwards. The Canaccord report noted that the Edwards Lifesciences TAVI franchise can produce close to $1 billion in revenue in 2015 as a result of continued expansion in Europe with Sapien XT, FDA approval of Sapien in the U.S. expected in late 2011, and approval in Japan expected in 2013. According to the report, “that would imply TAVI alone could double the current revenue run-rate for the entire company.“

Just this week, Edwards reported that an FDA advisory panel is scheduled to review its Sapien valve premarket approval application in July.

Elsewhere in the product pipeline:

• AngioDynamics (Albany, New York) has expanded its VenaCure EVLT system product offering with the global launch of the VenaCure 1470nm laser to treat varicose veins with greater energy efficiency. The VenaCure 1470nm laser's light energy is precisely delivered through the NeverTouch gold-tip fiber, and is more readily absorbed by the water in the blood and endothelial lining than is the case with other wavelengths. The NeverTouch fiber's jacketed tip has been engineered to maximize clinical efficacy and minimize post-operative pain and bruising. It has a lower power density and is designed to virtually eliminate the risk of direct contact between the laser fiber and vein wall. The EVLT system includes lasers available in both 1470 and 810 wavelengths, a choice of procedure kits, procedure accessories, a tumescent delivery system, practice and market development resources, and more.

• ArthroCare (Austin, Texas) received FDA clearance for its Spartan 6.5 Needled Anchor. The Spartan device is a preloaded threaded anchor indicated for use in fixation of soft tissue to bone, such as during a rotator cuff repair. The needled version is used for open repairs, whereas the non-needled version, for which FDA clearance has previously been received, is for arthroscopic repairs. The Spartan anchor has a 6.5 mm, screw-in design and can be used to perform single and double row repairs. A 5.5 mm version previously received FDA clearance. The Spartan anchor is manufactured from PEEK, (polyether-etherketone), a material widely used in orthopedic implants. More than 400,000 patients undergo rotator cuff surgery annually in the U.S.

• Bruker (Billerica, Massachusetts) reported a major extension of the successful maXis UHR Qq-TOF technology range, which Bruker will showcase at the ASMS 2011 conference in Denver. In March 2011, Bruker unveiled the maXis 4G system, setting entirely new performance heights with record-breaking 60,000 full-sensitivity resolution (FSR) and 600 parts-per-billion (ppb) mass accuracy at UHPLC speed. Delivering 40,000 FSR and 1 ppm mass accuracy, while acquiring at up to 50 full spectra per second, the maXis impact is the instrument of choice for high-throughput test laboratories, many of which are already equipped with UHPLC separations to raise throughput. With remarkable MS/MS sensitivity even at low mass fragments, the maXis impact rivals traditional triple-quad instruments in trace analysis quantitation, while offering all the flexibility and information content of precise-mass assignment and ultra-high resolution at UHPLC speed simultaneously, the company said.

• Cook Medical's (Bloomington, Indiana) 19-gauge EchoTip ProCore high definition ultrasound biopsy needle was the focus of study results that suggested a new, large-core biopsy needle designed for use with an endoscopic ultrasound (EUS) scope may help to overcome limitations of current EUS methods for biopsies of lesions in the gastrointestinal (GI) tract and surrounding tissue. EUS is an established procedure for diagnosing GI cancers and determining the stage of their development. Most often, a very fine needle is used – but fine-needle aspiration (FNA) can have limited yield and sensitivity for certain kinds of tumors or in some anatomical locations and only procures a cytological sample. The EchoTip ProCore needles circumvent this limitation by obtaining intact tissue samples, allowing for a histological diagnosis rather than conventional cytological diagnosis based on individual cells. In addition to this advantage, the needles are designed to access difficult-to-reach tissue in areas of the GI tract such as the pancreatic head.

• Covidien (Dublin, Ireland) reported both FDA approval and CE marking was granted to Parietex Optimized Composite (PCOx) mesh. PCOx is the next-generation version of Covidien's Parietex Composite (PCO) mesh, engineered to better address surgeon and patient needs in open and laparoscopic ventral hernia repair. Compared to the original product, the new product design incorporates a more resistant barrier and a proprietary textile design with better visibility and increased strength. PCOx mesh is three times more resistant than its predecessor, to aid in insertion and placement. Additionally, the new 3-D textile with x-stitch design is stronger and enables better visibility through the mesh. Importantly, PCOx has been shown in animals to promote rapid abdominal wall integration, minimize visceral attachments and facilitate strong tack fixation.

• Dilon Diagnostics (Newport News, Virginia) will introduce the latest advancement in molecular breast imaging (MBI) at the Society of Nuclear Medicine (SNM) Meeting in San Antonio, with the premiere of its Dilon 6800 Acella Gamma Camera system. The new camera will feature a much larger MBI detector which will make Dilon the first company in the industry to offer customers a choice in detector sizes. MBI, also referred to as Breast-Specific Gamma Imaging, is a functional imaging technique increasingly being used in the diagnostic workup of patients with indeterminate mammograms, particularly for those with dense breasts. Dilon believes its continued success can, in part, be attributed to its focus on the individual needs of each healthcare facility and personalized healthcare by providing customers with ongoing advancements such as larger field-of-view detectors and products like GammaLoc (the only FDA-cleared biopsy guidance platform for MBI). MBI uses radiotracer uptake to detect the increased metabolic activity of breast lesions and therefore, is not affected by breast density.

• Exactech (Gainesville, Florida) said its spine division has launched the Proliant Polyaxial Pedicle Screw System for orthopedic and neurosurgeons. This product launch represents the first spinal system developed in-house by Exactech. The company established its spinal division with two acquisitions over the past three years. The screw system is designed to provide secure fixation of the thoracolumbar spine while offering surgeons improved speed and ease-of-use. The pedicle screw has a dual lead thread for faster insertion and a patented Tightlok thread pattern that is designed to reduce screw pull out and facilitate fusion. The low-profile screw is designed to reduce the risk of tissue impingement, and the EZ Set tulip head allows the surgeon to easily position and set the tulip head in any position for rod insertion, creating a simple, easy-to-use posterior lumbar fixation system, the company said.

• IDEV Technologies (Webster, Texas) reported the completion of enrollment in the SUPERB trial, an FDA-approved IDE trial evaluating the use of IDEV's Supera stent system for treatment of peripheral artery disease in the superficial femoral artery (SFA). Enrollment was completed in May, making SUPERB one of the fastest enrolling SFA trials, the company said. The Supera Veritas transhepatic biliary system currently has FDA clearance for the palliative treatment of biliary strictures produced by malignant neoplasms. The SUPERB trial results will be used to support IDEV's pre-market approval (PMA) submission for an additional peripheral vascular indication. The Supera stent is indicated in the U.S. for the palliative treatment of biliary strictures produced by malignant neoplasms and in Europe, Canada and Australia for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty.

• Oceana Therapeutics (Edison, New Jersey) said the FDA has approved the Solesta sterile, injectable gel to treat fecal incontinence in patients for whom other therapies such as diet change, fiber therapy or anti-motility medications failed. The Solesta gel is injected into a layer of tissue beneath the anus lining and may help build tissue in that area. By growing the surrounding tissue, the opening of the anus narrows and the patient may be able to better control those muscles.

• Masimo (Irvine, California) reported FDA clearance, CE mark approval, and limited market release of its single-patient-use ear sensor. The Masimo E1 enables detection of oxygen saturation changes during low perfusion due to a variety of clinical factors, including sedative or medication-induced vasoconstriction. As a single-patient-use ear sensor that is placed securely in the cavum conchae (the deep hollow near the ear canal opening), the E1 allows clinicians to combine Masimo SET performance with a reliable alternative monitoring site while minimizing cross-contamination. This site frees up the patient's hands and is easy-to-access for clinicians. Made of soft silicone, it has no moving parts that can entangle in the hair or irritate the skin. By using the cavum conchae as the monitoring site, the E1 avoids the challenges associated with forehead sensors, including known limitations in the presence of venous pulsations and when patients are in a supine or trendelenburg position.

• Medical Compression Systems (MCS; West Hills, California) received FDA approval for the ActiveCare+Dx (temporary name) device developed on the basis of its flagship product, ActiveCare+S.F.T. The new product integrates venous obstruction prevention and detection capacities whereby both operations are carried out simultaneously during prophylactic therapy. This device detects venous obstructions in the patients' circulation while they occur and alerts about their formation. Currently, there is a 5%-6% risk of DVT formation amongst post-orthopedic surgery patients undergoing preventive drug or device therapy or a combination of the two. Using MCS's device will allow quicker identification of these patients and earlier treatment to begin, immediately after the presence of a blood clot is verified. Starting the therapy early could substantially reduce the occurrence of possible serious risks such as pulmonary embolism, which could be fatal.

Orthocon (Irvington, New York) reported FDA clearance for the Hemasorb Apply for clinical use and sale in the U.S. Hemasorb Apply is a custom-designed applicator preloaded with Hemasorb Absorbable Bone Hemostat Matrix. The product is provided ready-to-use and enables precise application of Hemasorb to stop bone bleeding during surgical procedures and in treating traumatic injuries. Currently marketed bone hemostat products require surgeons to use their fingers or surgical instruments for application. Hemasorb is putty-like in consistency, does not require preparation, and is now provided in a syringe-like applicator. Hemasorb is absorbable, biocompatible, and water resistant.

• Sophono (Boulder, Colorado) received FDA clearance for an implantable hearing device. The Otomag Alpha 1 Bone Conduction Hearing System is an alternative to traditional bone anchored hearing devices that require a through the skin abutment, typically called baha's. The Alpha 1 is a treatment for hearing disorders such as conductive and mixed hearing loss, as well as single sided deafness. It differs from currently available, implanted bone conduction hearing devices by using magnetic coupling. The Alpha system does not require an abutment (a titanium screw sticking out of the side of the head) or permanent hair removal and the daily hygiene routines required by an abutment. The Sophono device can be used by adults and children as young as 5 years old.

• ThermoGenesis (Rancho Cordova, California) received FDA clearance for the use of its Res-Q 60 (Res-Q) system technology to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point-of-care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The Res-Q 60 technology is a point-of-care platform designed for the preparation of cell concentrates. The company's first product, Res-Q 60 BMC is used to concentrate stem cells from bone marrow aspirate. A slightly modified version has been designed for use with peripheral blood in the preparation of a PRP concentrate. PRP is a rich source of growth factors which has been shown to enhance healing.

• Zimmer Holdings (Warsaw, Indiana) introduced the Maxera Cup, a new hip solution designed for younger and more active patients. The Maxera Cup features a large diameter femoral head that Zimmer claims provides an increased range of motion and enhanced stability. The full hemispherical design of the new cup provides stable fixation. The Maxera Cup uses Biolox delta Ceramic Technology which provides low wear, high fracture resistance and excellent bio-compatibility. The Maxera Cup is offered with Biolox delta and Biolox Option Large Diameter Heads (with sizes of 32 mm up to 48 mm). Large diameter heads offer a high degree of stability due to the increased displacement distance and allow a greater technical range of motion compared to conventional small diameter (28 mm) articulation.