Peripheral Arterial Disease News and Research

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Bioheart to establish two Centers of Excellence to provide cell therapy procedures for patients with CHF, PAD

Bioheart, Inc., announced today plans for establishing two Centers of Excellence in the Middle East to provide its cell therapy procedures to patients suffering from congestive heart failure and peripheral arterial disease. Dr. Karl E. Groth, Chairman and CEO, and Peggy A. Farley, Chief Operating and Financial Officer, are now in that region holding discussions and performing site inspections.

29 May 2010

New device to predict wound healing

Complex wounds affect more patients in the United States than heart attack and stroke combined. About 150,000 amputations a year result from complex wounds, while about 80,000 are attributed to diabetes and peripheral arterial disease. There are currently no established methods for early detection of wound healing, or for precise identification of healing progress.

27 May 2010

Cardiovascular Systems initiates enrollment in ORBIT II IDE clinical trial of Diamondback 360 System

Cardiovascular Systems, Inc., announces the first patient enrollment in its ORBIT II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360® System in treating coronary arteries. The patient was treated by Dr. P.K. Khanna, an interventional cardiologist with Eisenhower Medical Center in Palm Springs, Calif. Dr. Khanna also treated patients in the 2008 ORBIT I coronary study of 50 patients in India.

26 May 2010

Researchers develop new device that can change current landscape of chronic wound management

Complex wounds affect more patients in the United States than heart attack and stroke combined, and five to seven million Americans with complex wounds account for over $20 billion in healthcare expenditures. About 150,000 amputations a year result from complex wounds, while about 80,000 are attributed to diabetes and peripheral arterial disease.

25 May 2010

t2c001 product obtains certificate under EMA regulations for ATMPs

t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the quality of its lead product t2c001 has been certified by the European Medicines Agency.

25 May 2010

TriReme Medical receives FDA expanded clearance for GliderXtreme PTA balloon catheter

TriReme Medical, Inc. (TMI) announced today that it has received FDA clearance for an expanded matrix of sizes for its GliderXtreme™ PTA balloon catheter. GliderXtreme™ is now approved for the percutaneous transluminal treatment of lesions in the peripheral vasculature in balloon diameters from 2.0 – 5.0mm and in balloon lengths up to 200mm.

17 May 2010

$2.8 billion U.S. peripheral vascular device market to grow to over $5.3 billion by 2016

According to a new report by iData Research, the leading authority in medical device and pharmaceutical market research, the U.S. peripheral vascular device market is worth $2.8 billion with expected growth to over $5.3 billion by 2016. Increased detection and treatment of abdominal aortic aneurysms (AAAs) and peripheral arterial disease (PAD) are the main drivers of this market, particularly in the stent-graft and peripheral vascular stent segments. These markets are both expected to exceed $1 billion by 2016.

11 May 2010

Aastrom Biosciences reports third quarter 2010 FY results

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported financial results for its third fiscal quarter ended March 31, 2010, and also announced progress in its late-stage clinical development programs and corporate operations.

11 May 2010

CSI fiscal third-quarter revenue increases 9% to $16.5 million

Cardiovascular Systems, Inc. (CSI), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today reported financial results for its fiscal third quarter ended March 31, 2010.

6 May 2010

CSI announces completion of enrollment in CALCIUM 360° clinical trial for PAD

Cardiovascular Systems, Inc. (CSI), has completed patient enrollment in its prospective, randomized CALCIUM 360° clinical trial, part of the company's 360° Clinical Series. The CALCIUM 360° feasibility study is evaluating the treatment of peripheral arterial disease (PAD) behind and below the knee using CSI's Diamondback 360® System, a minimally invasive catheter for treating PAD anywhere in the leg. Dr. Nicolas Shammas, an interventional cardiologist at Trinity Medical Center, Bettendorf, Iowa, is the study's principal investigator.

30 Apr 2010

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

Cardiovascular Systems, Inc., has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010.

28 Apr 2010

BioMedix TRAKnet software suite receives APMA Seal of Acceptance

Today, the BioMedix TRAKnet software suite was granted the prestigious American Podiatric Medical Association (APMA) Seal of Acceptance. BioMedix is the only company to receive the APMA Seal of Acceptance for Electronic Health Record and Practice Management software.

28 Apr 2010

ev3 completes enrollment in study of EverFlex Self-Expanding Stent System for SFA

ev3 Inc. today announced the completion of patient enrollment in the DURABILITY II trial, a prospective, multi-center, single-arm study evaluating the EverFlex® Self-Expanding Stent System for the treatment of superficial femoral artery (SFA) and proximal popliteal lesions. The DURABILITY II study will support a planned Premarket Approval (PMA) filing with the U.S. Food and Drug Administration to obtain approval of the EverFlex Self-Expanding Stent System for use in the SFA.

26 Apr 2010

Complete revascularization reduces mortality rate in CAD patients

A 3-year, retrospective study by cardiologists from the Minneapolis Heart Institute Foundation and the University of Minnesota determined that 28.8% of patients with significant coronary artery disease (CAD) who did not undergo complete revascularization had a higher mortality rate than patients completely revascularized. Results of this study appear in the May issue of Catheterization and Cardiovascular Interventions, a journal published by Wiley-Blackwell on behalf of The Society for Cardiovascular Angiography and Interventions.

24 Apr 2010

Study: 28.8% of CAD patients who fails to undergo complete revascularization face higher mortality rate

23 Apr 2010

SVS publishes first supplement on diversity articles to Journal of Vascular Surgery

The Society for Vascular Surgery published its first supplement on diversity articles to its Journal of Vascular Surgery in April 2010.

23 Apr 2010

FDA approves Medtronic's Complete SE Vascular Stent System for PAD

Broadening the scope of innovation for cardiovascular interventions beyond the heart, Medtronic, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for the Complete® SE Vascular Stent System to be used for the treatment of peripheral arterial disease (PAD) in the iliac arteries, major blood vessels within the pelvis that supply blood to the lower extremities.

21 Apr 2010

CSI establishes $25M credit facility with Silicon Valley Bank

Cardiovascular Systems, Inc., announced today that it has established a $25 million credit facility with Silicon Valley Bank and up to $4 million in convertible debt with Partners for Growth. Proceeds will be used to consolidate existing outstanding debt, provide working capital for growth and for general corporate purposes.

21 Apr 2010

Successful stem cell therapy performed on CHF patients in Mexico

Bioheart, Inc. announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart's Center of Excellence program with Regenerative Medicine Institute.

15 Apr 2010

SIR, Custom Computer Specialists sign licensing agreement to promote development of HI-IQ

The Society of Interventional Radiology and Custom Computer Specialists Inc. have entered into an exclusive, long-term licensing agreement to promote innovation and the development of HI-IQ-, the leading information management system for interventional radiology.

8 Apr 2010