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In a purchase totaling about $1.03 billion, Medtronic has acquired two privately-held manufacturers of heart valve technologies. Although the products developed by CoreValve Inc. (Irvine, CA) and Ventor Technologies Ltd. (Netanya, Israel) aren’t on the U.S. market yet, the deal is a long-term strategic move for the company, according to Frost & Sullivan medical device analyst Venkat Rajan. He adds that the heart valve market is on the cusp of transition, as it is moving more towards percutaneous heart valve repair and replacement.  These minimally invasive technologies open the door to a new patient population. Additional benefits include faster recovery times and lower risks of infection, both of which address major restraints that have prevented patients from receiving treatment in the past. 

Ventor Technologies, which was purchased for $325 million, has developed the Ventor Embracer, a system that enables a transapical, minimally invasive approach to replacing aortic valves. CoreValve, acquired for $700 million, makes the ReValving System, which allows surgeons to replace an aortic valve by inserting a catheter through an artery in the groin. 

Michael Baker, president and CEO of ArthroCare Corp. (Austin, TX), has stepped down following an announcement that the company is under investigation by the Security and Exchange Commission. The Audit Committee is looking into whether the company engaged in improper practices in insurance billing and healthcare compliance practices related to Arthrocare’s spine business unit. The company is also being investigated by the U.S. Attorney’s offices in Florida and North Carolina. Michael Moehring, VP and general manager of the spine unit, and Michael Denker, director of sales development and training, also resigned. The improper practices identified date back to at least 2006. Evidence includes instances in which Arthrocare engaged in making inaccurate statements in claims submitted to insurers regarding the place where certain procedures were performed and giving doctors and insurers descriptions of company technologies that had the effect of circumventing payor policies that didn’t cover the technologies.  The Audit Committee was told that certain sales and marketing staff within the spine unit were giving doctors and their billing staff merchandise and administrative services at no charge, which were possibly in exchange for using the company’s products. It also determined that personnel at all levels didn’t have adequate training and supervision in insurance reimbursement requirements. The committee is reviewing practices in other business units as well. 

The most recent study comparing results of percutaneous coronary intervention (PCI) with stents versus bypass surgery concludes that bypass remains the standard of care in certain patients, because it results in a lower incidence of major adverse cardiac events. So, is bypass surgery better than getting a stent implant? Well, there isn’t a simple answer to this, but experts think that some doctors might use the data to present patients with both options (not to say that many physicians don’t do that already). The study was published online yesterday by The New England Journal of Medicine and will appear in the March 5 print edition. It found rates of major adverse cardiac events were much higher in the PCI group at 17.8%, because of the higher rate of repeat revascularization at 13.5% (the bypass group only had a 5.9% rate of repeat revascularization). L. David Hillis, MD, a doctor who wrote an editorial in NEJM about coronary revascularization and the recent study, points out that not every patient has the luxury to choose from both procedures. While the study has its strengths, Hillis writes that its limitations include too short of a follow up period and the fact that most of the patients involved were men (78%). 

FDA has cleared Power Medical Interventions’ i60RL intelligent surgical instrument, the world’s first reverse pivot linear cutter. The device gives surgeons access to hard-to-reach parts of the body and is indicated for use throughout the digestive tract.  It is part of the company’s Intelligent Surgical Instruments line, which are computer-assisted and power-actuated mechanical instruments used in both open and minimally invasive procedures for cutting, stapling, and tissue manipulation. The company also was approved to use the i60RL to study its treatment of gastroesophageal reflux disease. An April product launch is planned.  

Symmetry Medical Inc. (Warsaw, IN) is growing with the baby boomer market and is ready to accommodate any needs of the expanding orthopedic equipment market. This news is according to the manager of the company’s plant in New Bedford, MA. The facility was acquired by Symmetry Medical in January 2008, and since then, the plant has seen a huge increase in sales, from $291 to $420 million (it also added 59 jobs). In addition, senior vice president William Frey says the company is predicting 14 to 15% growth this year, following last year’s record numbers. Other areas of success for Symmetry, at least at its New Bedford plant, include its strategy for recruiting top talent. The company works with vocational high schools and area colleges and universities to find potential candidates for its co-op and internship programs. Internal training programs are also in place to help employees raise their qualifications to become high-level machinists.

Medtronic’s businesses, including its cardiovascular, spinal, and surgical segments, continue to grow despite “global macroeconomic uncertainties,” said CEO Bill Hawkins this morning. This year’s total third quarter revenue (ending 1/23/09) reached $3.5 billion, which was a 3% increase over 3Q 2008. Surgical technologies grew 6% and were enhanced by sales of its Navigation equipment. Spinal revenue hit $832 million (3 to 4% growth after adjusting for foreign exchange impact), with core business growth attributed to the adoption of the Legacy, Atlantis, and MAST (minimal access spinal technologies) product lines.  The CardioVascular business reached $565 million, experiencing a 10% growth (coronary stent revenue also grew 25%). A more detailed breakdown can be found on Medtronic’s site. 

Smith & Nephew plans on joining the U.S. extremities surgical products market this year, along with building a business unit in Memphis, TN, reports the Memphis Commercial Appeal. According to Joseph DeVivo, president of the company’s Orthopaedic Reconstruction Division, Smith & Nephew entered the extremities business following its purchase of Plus Orthopedics two years ago, which offered an implant for total shoulder replacements. Although the modular implant, called Promos, has been available in the United States, Smith & Nephew is preparing a full-scale launch of it next year and will be introducing it to surgeons this year in order to build the U.S. market for the product. 

Tiny springs made by Bal-Seal Engineering Inc. (Foothill Ranch, CA) might help orthopedic device designers improve the performance of their products without making big changes to design needs or cost. For demonstration purposes, the company integrated its canted-coil spring technology into a carpometacarpal (CMC) device to provide smoother rotary motion. A CMC device can be used to replace diseased or arthritic joints and restore movement. In Bal-Seal’s particular concept, the spring preloads the ball in a socket lined with ultrahigh molecular weight polyethylene. Smaller springs that are affixed to pins retain plates the restrict joint movement to two axes. The device concept hasn’t gone through clinically testing. A video animation posted on the company’s Web site shows the coil spring technology being used with a CMC device. 

Galway, Ireland-based Creganna has acquired the technology and patents of Micromuscle AB (Linkoping Sweden). Micromuscle electroactive polymers work similar to human muscle and can be integrated into devices, especially those used in interventional cardiology and percutaneous transluminal coronary angioplasty. The polymer swells and contracts in response to a 1- to 2-volt electrical stimulus. Applications in which the technology can be applied include guidewires, stents, catheters, and balloons for new functionality. Check out this video: Here, the technology is used inside blood vessels to control motion and position components (from outside the body). 

The acquisition of Micromuscle AB’s technology and patents happened after the company was forced to seek voluntary liquidation. Creganna is keeping Micromuscle’s technical employees for technology transfer and is working with the company’s former customers on development projects. 

As an answer to the rise of surgical site infections (SSIs), a new company has been launched to fight SSIs in spinal procedures. DiFUSION Technologies (Austin, TX) developed an antimicrobial PEEK spinal interbody cage that can stop biofilms from forming in a bone graft site. Called CleanFUZE, the technology uses a silicate molecule made of antimicrobial silver ions that it compounded into a plastic spinal interbody cage. When the cage is implanted, the silver ions exchange with sodium ions in the bloodstream and are diffused over four weeks, which can lead to the elimination of 650 types of bacteria, including MRSA. By improving infection rates, the device also prevents additional surgeries, antibiotic use, and more serious infection dangers such as amputation and death. DiFUSION has already reported successful testing of the implant and will be seeking FDA clearance by the end of this year.    

The company is funded by angel investors and is looking for a second round of funding for nationwide marketing and sales support. It plans on positioning 200 to 300 sales representatives to prepare for the launch of CleanFUZE.