Medtronic Inc. (MDT) recently launched a new TSRH 3Dx Spinal System, which is a hook, rod and screw system used in complex spinal procedures. The system offers two screws designed to address multiple pathologies. The Multi Planar Adjusting (MPA) Screw gives surgeons the flexibility of a variable angle posted screw for targeted, controlled correction maneuvers. The OSTEOGRIP Screw enhances bone fixation by incorporating a dual-lead thread pattern that reduces toggle at the bone-screw interface.

The new pedicle screw system has a unique technology that addresses multiple spinal pathologies, from degenerative disc disease to spinal deformity. The product offers an alternative to patients for spinal stabilization with fusion. It works for patients suffering from degenerative spinal conditions, deformity, or injury of the thoracic, lumbar, and sacral spine. The TSRH Spinal System also provides Chromaloy rods and a minimally invasive capability.

We think that the new product will be widely accepted by

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Medtronic, Inc. (MDT) recently launched MASTERGRAFT Strip - a new, highly flexible ceramic scaffold used in combination with a patient’s own bone for fusing multiple levels of the posterolateral spine, in the U.S. The strip is used by surgeons for a variety of bone grafting procedures.   MASTERGRAFT Strip is primarily used when the spine loses stability or its natural shape. The product offers a continuous latticework for longer grafting procedures at the back of the spine. It also enables maximization of the bony surface area contact and allows for continuous bone growth over large bony gaps. MASTERGRAFT Strip is available in unique lengths that eliminate the requirement of multiple strip units for a long fusion.   MASTERGRAFT Strip’s unique features and ease of handling during implantation makes it a preferred choice for spine surgeons. We therefore expect the product to increase the Spinal and Biologics business

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Medtronic Inc. (MDT) recently reported the first enrollment for its Attain Success trial. The trial evaluates implant success, complication rates and procedure times for the company’s Attain Family of left-heart leads and delivery systems portfolio which are already available in the market.  The Attain Success trial enrollment will have roughly 2,000 patients at 150 medical centers in 18 countries around the world. The company will analyze data at baseline, implant and three months post-implant. The study will also capture implant success and complication rates (up to three months), procedure times, handling feedback and physician survey data.  In addition, the Attain Success trial enrollment will have a sub-study that will assess final left-heart lead placement site. Patients enrolled in the test will have a cardiac resynchronization therapy-defibrillator (CRT) device implanted in them. Results from the test are expected in 30 months.  If successful, the Attain Success ...

Volcano Corporation (VOLC) reported a net loss of 5 cents in the third quarter, narrower than the Zacks Consensus Estimate for a net loss of 12 cents. Although third-quarter revenues increased 22% from the year-ago period, earnings declined from last year's profit of one penny, mainly due to higher operating expenses.

Third quarter revenues came in at $54 million. Revenues included $4.6 million from Axsun Technologies, Inc, which was acquired by Volcano in late 2008.

Although intravascular ultrasound (IVUS) systems sales declined 20% to $8.4 million, sales of IVUS disposables increased 15% to $31.3 million. Growth in the Japanese market remained strong at 22%. Meanwhile, the U.S. market recorded growth of 16% in IVUS disposable sales. Functional Measurement (FM) device sales increased a whopping 53% to $7.6 million, led by more than 75% growth in the U.S. and rest-of-the-world (ROW) countries.

Data presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting showed

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Medtronic, Inc. (MDT) recently started a feasibility study of an interventional treatment for erectile dysfunction (ED) using a specially designed drug-eluting stent system. The study is known as ZEN (Zotarolimus-Eluting Peripheral Stent System for the Treatment of Erectile Dysfunction in Males with Sub-Optimal Response to PDE5 Inhibitors) and is being conducted under an investigational device exemption (IDE) issued by the U.S. Food and Drug Administration (FDA).   The study is expected to enroll 50 patients at up to ten medical centers in the United States over 2010. It has been seen that there is a link between erectile dysfunction and coronary artery disease. ED is primarily caused by vascular disease due to the deterioration of the endothelium. Medtronic’s drug-eluting stent preserves endothelial function of the native vessels. The study evaluates the safety and enhanced erectile function of pelvic artery stenting. Results are expected in 2011.      If successfully

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Medtronic, Inc. (MDT) yesterday reported positive results from the study of the safety and effectiveness of the company’s INFUSE Bone Graft compared to autogenous bone graft when used in maxillary sinus floor augmentation. Results indicated that INFUSE Bone Graft are equally effective as autogenous bone graft for sinus lifts, a common dental surgical procedure. Additionally, INFUSE Bone Graft avoids harvesting autogenous bone -- that is, bone taken from the patient’s body -- and thereby eliminates the associated morbidity, cost and increased surgical time. The bone generated by INFUSE Bone Graft is normal, mature and 100% viable with no residual graft material. It has been estimated that roughly 100,000 patients in the U.S. are indicated for a sinus lift augmentation to place dental implants. Severe bone loss results mainly from disease, trauma or genetic defects. We think that the new device brings an alternative treatment option ...

St. Jude Medical Inc. (STJ) recently made a $15 million equity investment in Micell Technologies, a small company that operates in the niche market of developing drug-coated stents.

We view this as St. Jude’s strategy to acquire Micell in future and bolster its position in the cardiovascular segment. However, the investment does not give St. Jude a right to have a voting member in Micell’s board. Other details of the deal were not disclosed.

Micell’s drug-coated stents are less likely to produce blood clots than drug-eluting stents. A stent is a small metal tube used in surgeries to open up clogged arteries.

The equity investment provides Micell with a partner and funding source for exploring other applications in coating technology.

St. Jude Medical is a leading medical device manufacturer that designs, manufactures and distributes medical devices to treat cardiovascular and neurological conditions. The company operates through four business

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Medtronic, Inc. (MDT) recently launched the KYPHON Cement Delivery System (CDS) in the U.S. on a full-scale basis. The new product is an addition to the company’s extensive KYPHON Balloon Kyphoplasty product portfolio used for the treatment of vertebral compression fractures (VCFs).  The KYPHON Cement Delivery System enables physicians to maintain a safer and longer distance from the radiation source during the cement delivery phase compared to the company’s traditional delivery system. It decreases the radiation exposure exponentially. The new product launch is a shot in the arm for Medtronic as it will increase sales in the Spinal and Biologics segment and strengthen the company’s leadership position in this market. Spinal is Medtronic’s second-largest revenue generating segment, representing roughly 23% of total revenues.  The company has widely used its balloon kyphoplasty products with an estimated over 700,000 fractures treated globally till date. Medtronic is one of ...

Medtronic, Inc. (MDT) is recalling some LifePak CR defibrillators as humidity may cause them to malfunction. These defibrillators were manufactured and distributed between July 9 and August 19 in 2008. The company started the process of recalling the products from July 31, 2009. Defibrillators are designed to fix abnormal heart rhythms by delivering electric shocks. The affected products may break down in extreme humidity as they may fail to analyze the heart rhythm correctly. The device might not affect any electric shocks or delay sending electric shocks, which may seriously injure the patient. The products were manufactured by the company’s Physio-Control unit. Though the magnitude of the product recall has not been disclosed, we think that this will hurt Medtronic’s bottom-line in the near-term. We can correctly estimate when the extent of product recall becomes known. However, we believe that this recall will have a minimal ...

Medtronic, Inc. (MDT) has recently warned doctors that approximately 6,300 of the company’s implanted heart devices have battery drainage problem that might reduce the life-span of these batteries. Certain batches of Medtronic’s Concerto and Virtuoso devices manufactured in 2006 are affected with this problem. The company’s share reacted negatively to this news with the price declining roughly 2.8% to $37.90 at the end of Sep 11, 2009. Concerto is a CRT-D (cardiac resynchronization therapy defibrillator) that enables the lower chambers of the heart to pump blood at the same time. Virtuoso is an ICD (implantable cardioverter defibrillator) that takes care of abnormal heart rhythms. The affected batteries might have to be replaced a few months earlier than their normal life-time. The drainage problem has not resulted in any safety problems and there is no risk of a sudden power loss yet. Furthermore, no injuries have been ...