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Abbott receives US regulatory clearance and Japanese approval for TREK Coronary Dilatation Catheters

Abbott today announced it has received regulatory clearance in the United States and approval in Japan for its TREK and MINI-TREK Coronary Dilatation Catheters for the treatment of coronary artery disease. The TREK system is used in angioplasty procedures and is designed to enable interventional cardiologists to open patients' narrowed coronary arteries. The TREK system received CE Mark and was launched in Europe in May 2010.

1 Feb 2011

Cappella initiates multi-center Italian Sideguard open label clinical study

Cappella Medical Devices announces initiation of the multi-center Italian Sideguard® open label clinical study. The Principal Investigator (PI) of the study, Dr. Giuseppe Massimo Sangiorgi at the Policlinico di Modena - University of Modena and Reggio Emilia, in Modena, Italy stated, "The side branch ostium anatomy requires a unique technology solution to effectively manage and optimize treatment.

1 Feb 2011

Boston Scientific initiates enrollment in comparative Chinese study of PROMUS Element Everolimus-Eluting Stent

Boston Scientific Corporation today announced the beginning of patient enrollment in the PLATINUM China clinical trial, which is designed to evaluate the safety and effectiveness of the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent compared to the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent in the treatment of patients with a single de novo atherosclerotic lesion.

27 Jan 2011

St. Georg Hospital performs two live procedures using Endoscopic Ablation System

CardioFocus announced that two "live cases" using its Endoscopic Ablation System were recently conducted. The first live case was a satellite transmission performed at Centro Cardiologico Monzino in Milan, Italy; broadcast to the 16th Annual Boston Symposium on Atrial Fibrillation in Boston, MA.

25 Jan 2011

Biomerix receives CE Mark approval for REVIVE soft tissue repair mesh

Biomerix Corporation announced today that it has received CE Mark approval for its REVIVE™ soft tissue repair mesh allowing for the marketing of REVIVE in all European Union member (EU) states. REVIVE received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January 2009.

24 Jan 2011

USC School of Medicine to host the first World Congress of Ultrasound in Medical Education

Ultrasound is a valuable tool that allows doctors to diagnose and treat patients quickly and accurately. It's been around for decades, but there has been revolutionary change in the technology in recent years, making the machines smaller, cheaper and smarter.

21 Jan 2011

First IRB approval for clinical study on the abdomen utilizing Revolutions Medical MRI software tools

Revolutions Medical has received notice that Investigational Review Board (IRB) approval has been granted to Dr. Yong Wei, Assistant Professor of Computer Science at North Georgia College and State University (NGCSU) and Dr. H. Keith Brown, Professor of Anatomy at the Philadelphia College of Osteopathic Medicine (PCOM-GA) for their clinical study 'Statistical Analysis of Abdomen Tissue Segmentation by Color Fusion MRI.'

19 Jan 2011

Loyola offers new, nonsurgical treatment for Dupuytren's contracture

Loyola University Health System is among the first centers to offer a new, nonsurgical treatment for Dupuytren's contracture, a debilitating condition that curls fingers toward the palm.

19 Jan 2011

Study: Brain's 'autopilot' network may aid in early diagnosis of Alzheimer's disease

Watching the brain's "autopilot" network in real time may help determine the onset of cognitive decline and potentially aid in making an early diagnosis of Alzheimer's disease, according to researchers at Duke University Medical Center.

19 Jan 2011

Health Canada approves GORE VIABIL Biliary Endoprosthesis device

W. L. Gore & Associates, Inc. today announced it has received approval from Health Canada for the Removable GORE VIABIL Biliary Endoprosthesis.

17 Jan 2011

US Army awards $2.8M contract for project focusing on brain and eye injuries in military personnel

The Virginia Tech-Wake Forest University Center for Injury Biomechanics (www.cib.vt.edu) has been awarded a $2.8 million contract from the U.S. Army Medical Research and Materiel Command for phase 2 of an overall project focusing on brain and eye injuries in military personnel. Specifically, blast induced brain trauma will be investigated using experimental and computational models.

14 Jan 2011

Endosense, Siemens Healthcare enter joint catheter ablation development project

Endosense, a Swiss medical technology company, and Siemens Healthcare, one of the world's largest suppliers to the healthcare industry, have agreed to commence a joint development project intended to integrate the contact-force data provided by Endosense's TactiCath® force-sensing ablation catheter with Siemens' electrophysiology solutions.

14 Jan 2011

BIOTRONIK announces FDA IDE approval and first patient enrollment for TOCCASTAR clinical trial

BIOTRONIK SE Co. & KG highlights two key milestones toward receiving premarket approval (PMA) of the TactiCath, a novel technology for treating atrial fibrillation (AF): FDA IDE (investigational device exemption) approval and the first patient enrollment of the TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) clinical trial.

14 Jan 2011

12-HETE enzyme inhibition can prevent ischemic retinopathy: Study

The inhibition or removal of an enzyme may prevent or treat ischemic retinopathy by stalling growth of unwanted vessels in the retina, Medical College of Georgia researchers say.

14 Jan 2011

Emotional stress can affect motor coordination and other cerebellum-dependent cognitive functions: Study

Research conducted by Iaroslav Savtchouk, a graduate student, and S. June Liu, PhD, Associate Professor of Cell Biology and Anatomy at LSU Health Sciences Center New Orleans, has shown that a single exposure to acute stress affected information processing in the cerebellum - the area of the brain responsible for motor control and movement coordination and also involved in learning and memory formation.

13 Jan 2011

Stereotaxis announces first successful cardiac ablation procedure with Vdrive robotic navigation system

Stereotaxis, Inc. announces the first successful cardiac ablation procedure with the Vdrive™ robotic navigation system as the company received CE Mark for this latest innovation.

11 Jan 2011

European CE Mark approval for IntraPace's abiliti system

IntraPace, announced today that it has received European CE Mark approval for the abiliti system as a treatment for obesity. The CE Mark certifies that a product has met European Union requirements for commercial marketing in Europe.

11 Jan 2011

CMI, TriReme Medical sign agreement to distribute peripheral and coronary balloon dilatation catheters

TriReme Medical, today announced that it has signed an exclusive distribution and sales agreement for TriReme's complete line of advanced peripheral and coronary balloon dilatation catheters with Century Medical, a leading independent device distributor for the important Japanese market.

10 Jan 2011

Administration of therapeutic hypothermia for TBI should depend on clinical condition of individual patients

Lowering the body temperature of patients soon after they have suffered a severe brain injury may reduce neurologic complications and improve outcomes. The safety of therapeutic hypothermia for traumatic brain injury (TBI) has been demonstrated in national studies. According to a Roundtable Discussion of renowned experts in the field, when and how it is administered should depend on the clinical condition of individual patients.

5 Jan 2011

FDA approves Gore's C3 Delivery System to deploy EXCLUDER AAA Endoprosthesis

W. L. Gore & Associates (Gore) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the GORE® C3 Delivery System to deploy the GORE® EXCLUDER® AAA Endoprosthesis as a minimally invasive treatment for patients suffering from an abdominal aortic aneurysm (AAA).

5 Jan 2011

Anatomy News and Research

Abbott receives US regulatory clearance and Japanese approval for TREK Coronary Dilatation Catheters

Cappella initiates multi-center Italian Sideguard open label clinical study

Boston Scientific initiates enrollment in comparative Chinese study of PROMUS Element Everolimus-Eluting Stent

St. Georg Hospital performs two live procedures using Endoscopic Ablation System

Biomerix receives CE Mark approval for REVIVE soft tissue repair mesh

USC School of Medicine to host the first World Congress of Ultrasound in Medical Education

First IRB approval for clinical study on the abdomen utilizing Revolutions Medical MRI software tools

Loyola offers new, nonsurgical treatment for Dupuytren's contracture

Study: Brain's 'autopilot' network may aid in early diagnosis of Alzheimer's disease

Health Canada approves GORE VIABIL Biliary Endoprosthesis device

US Army awards $2.8M contract for project focusing on brain and eye injuries in military personnel

Endosense, Siemens Healthcare enter joint catheter ablation development project

BIOTRONIK announces FDA IDE approval and first patient enrollment for TOCCASTAR clinical trial

12-HETE enzyme inhibition can prevent ischemic retinopathy: Study

Emotional stress can affect motor coordination and other cerebellum-dependent cognitive functions: Study

Stereotaxis announces first successful cardiac ablation procedure with Vdrive robotic navigation system

European CE Mark approval for IntraPace's abiliti system

CMI, TriReme Medical sign agreement to distribute peripheral and coronary balloon dilatation catheters

Administration of therapeutic hypothermia for TBI should depend on clinical condition of individual patients

FDA approves Gore's C3 Delivery System to deploy EXCLUDER AAA Endoprosthesis

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