IMDA Technology Briefs

Edition: October 2001 - Vol 9 Number 10
Article#: 1074
Author: Repertoire

ArthroCare Corp. (Sunnyvale, CA) reported that the FDA granted the company expanded clearance to market its Coblation®-based disposable surgical devices for over 40 specific arthroscopic indications in the knee, shoulder, wrist, ankle, elbow and hip. The expanded clearance covers approximately 160 orthopedic procedures and is said to represent the broadest array of specific indications approved for any company marketing radio frequency surgical equipment for arthroscopic and orthopedic applications. (

Bio-Plexus Inc. (Vernon, CT) announced that it has begun fulfilling customer orders for its PUNCTUR-GUARD® Safety Winged Set for blood collection, for which it received FDA 510(k) marketing clearance in January 2001. Winged sets are steel hollow-bore needles with attached tubing used for blood collection. The PUNCTUR-GUARD Winged Set incorporates the same internal blunting technology used in the company's PUNCTUR-GUARD multisample blood collection needle. Upon activation, an inner hollow blunt needle extends beyond the sharp point of the outer needle prior to removal of the device from the patient, thereby eliminating the exposure to sharp, contaminated needles. (

Each year more than 1.5 million patients show up in emergency rooms complaining of chest pain, but only a small percentage are actually having heart attacks. A study in the July 2001 Journal of the American College of Cardiology has revealed a way to determine which patients require hospitalization and which ones can be safely discharged – an imaging technique called electron beam tomography, which detects the presence of calcium in the arteries. The researchers found that the presence of coronary artery calcium was strongly related to the patients' chances of heart attack, other problems, or death. Noting that the absence of coronary artery calcium is associated with a very low risk of future cardiac problems, the researchers concluded that electron beam tomography is a safe, efficient way to determine which patients can be discharged without fear.

Cardima Inc. (Fremont, CA) received a patent for its REVELATION Tx microcatheter system for the treatment of atrial fibrillation, an estimated $6 billion market. The microcatheter includes small, coiled electrodes designed to conform to atrial tissue and to create narrow ablation paths. The patent also includes claims for a method of linear ablation, which allows physicians to perform minimally invasive linear surgical cuts.

Criticare Systems Inc. (Milwaukee) received FDA clearance to market its new 5-agent solid-state anesthetic gas monitor. The Poet® IQ's performance criteria are said to include auto recognition, fast warm up, self-calibration, and low energy consumption, all in a compact modular system. In addition, its measurement accuracy is not affected by the presence of alcohol, a common source of interference. (

Endius Inc. (Plainville, MA) launched its new Bipolar Sheath, which is designed to dramatically reduce blood loss during EndoFusion surgery, a minimally invasive approach to posterior spine fusion pioneered by Endius. The company says that bipolar energy is safer and more effective than monopolar energy because it significantly reduces the risk of nerve and tissue damage. (

Demand is surging for endoscopic procedures, primarily because of the growing population of Americans 45-years-old and older, according to a report from San Jose, CA-based Frost & Sullivan ( The report, "U.S. Endoscopic Visualization Equipment Market," reveals that the industry generated revenues of more than $310 million in 2000 and will surpass $455 million by 2007. "Millions of Americans every year undergo colonoscopies, bronchoscopies and knee surgeries, where endoscopes are used," says Frost & Sullivan Medical Device Analyst Charlie Whelan. "The special cameras, fiberoptic light sources, monitors and recording equipment physicians use in conjunction with the endoscopes make these procedures possible." Advances in digital imaging and the use of flat-screen monitors are revolutionizing the field of endoscopy, says the company.

ESTECH, Inc. (Danville, CA) announced that surgeons at New York's Columbia Presbyterian Hospital repaired a congenital heart defect without opening the patient's chest using a surgical robot and the ESTECH Remote Access Perfusion (RAP) Cannula. The device is designed to deliver oxygenated blood to patients undergoing "stopped heart" surgical procedures without requiring an opening through the chest. It is inserted through a small access site in the femoral artery at the groin, and then guided into the ascending aorta, close to the heart. Also, instead of mechanically clamping the aorta to block blood flow during the procedure, as in conventional procedures, the cannula occludes the aorta by simple inflation of an atraumatic balloon. (

Hatch Medical L.L.C. (Atlanta), a medical device incubator and technology brokerage firm (, signed an agreement with physician inventor Aubrey Palestrant, M.D. for his vascular access technology consisting of four proprietary patents. Together, they will create FlatCath L.L.C., a joint venture, to develop and market it. The technology is intended to improve catheter patency and longevity while minimizing vessel trauma and thrombus formation. Large, multi-lumen catheters are regularly placed into the venous system to perform hemodialysis, infusion or aspiration. Catheter placement often creates turbulence and sluggish blood flow resulting in a myriad of patient-related health concerns. Palestrant's patents are said to allow for a catheter design that significantly decreases its cross-sectional dimensions within the blood vessel when the catheter is not in use.

Equidyne Corp. (San Diego) received FDA clearance to market the INJEX™ single-use disposable, needle-free drug delivery system. Unlike other INJEX™ systems, which include a multiple-use stainless steel injector and single-use disposable medication ampule, the new INJEX™ integrates a ''jet injection'' device and disposable ampule all in one.

Micronet Medical Inc. (St. Paul, MN) received FDA marketing clearance for its Axxess™ Spinal Cord Stimulation Lead, which, at 0.83 mm in diameter, is said to be the smallest-diameter neurostimulation lead in the market. It is designed to be used as part of a spinal cord stimulation system and is used to aid in the management of chronic, intractable pain of the trunk and limbs. About 22 million people suffer from back and neck pain in which spinal cord stimulation may be helpful, according to a study by U.S. Bancorp Piper Jaffrey.

TransTracheal Systems Inc. (Englewood, CO) has developed an inpatient surgical procedure for otolaryngologists called Fast Tract™, said to make it easy to provide life-extending transtracheal oxygen therapy with the company's SCOOP® oxygen catheter to oxygen-dependent patients, while reducing healing time compared to the traditional outpatient method. The company says that oxygen is most effective when delivered directly to the lungs, 24 hours a day, which SCOOP catheters are designed to do. The catheters are said to draw less oxygen from the patient's tank but deliver more oxygen to the bloodstream, compared to nasal cannula. (

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