August 2013 Product News
firmed that the COMBO Stent is as effective as a monotherapy drug-eluting stents, with respect to in-stent late lumen loss at nine-month angiographic follow-up. These data were used to support CE mark approval for COMBO.
“Late-stent throm- bosis is still a concern for patients treated with monotherapy drug-eluting stents, leaving them de- pendent on a minimum of six months DAPT,” said Michael Haude, direc- tor of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, and principal investigator of the REMEDEE trial. “We also know that cessation of DAPT is the single most significant predictor of stent thrombosis for these patients. If cessation of DAPT is necessary, the Combo stent may enable us to stop DAPT without causing a catastrophic event. Thus the Combo
stent has the potential to bring the best of both worlds together, balancing safety and efficacy.” The addition of Or- busNeich’s proprietary pro-healing antibody surface coating provides protection against stent thrombosis by capturing endothelial progenitor cells circulating in the blood to the device to form a functional endothe- lial layer.
Boston Scientific launch new
coronary imaging catheter in Europe and USA
After receiving both CE mark and FDA approval for its new coronary imaging catheter, Boston Scientific has announced that it has launched the “OptiCross” in Europe and in the USA. It plans to launch the catheter in Japan later this month. According to a press release, the OptiCross is a
next-generation intravas- cular ultrasound (IVUS) catheter that offers better deliverability and higher resolution imaging to fa- cilitate complex coronary procedures.
The press release reported that the device is designed to be com- patible with the Boston Scientific iLab ultrasound imaging system and was created with the input of physicians from around the world to reduce the inherent challenges sur- rounding catheter delivery in complex cases. The upgraded, low-profile delivery system features five French guide catheter compatibility, a shorter, tapered tip, a bi-segmented catheter shaft and a rede- signed catheter hub for ease of connection.
“The OptiCross catheter was designed for optimal deliverability and its performance proves it,” said Matthew Price, interventional cardiologist
and director of the Cardiac Catheterization Laborato- ry, Scripps Green Hospital, San Diego, USA. “Now I can use IVUS technology in complex cases where I would not have been able to deliver an IVUS catheter before.”
FDA approves labelling change for balloon catheter
AngioScore has an- nounced that the FDA has approved a premarket sup- plement (PMAS) labelling change for its AngioSculpt scoring balloon catheter, which means the company can now include a sum- mary of the AGILITY coronary bifurcation trial results in the catheter’s instructions for use. According to a com- pany press release, the AGILITY trial enrolled 93 patients with com- plex “true” coronary bifurcation lesions at nine premier interventional cardiology programmes in the USA and followed these patients for nine months. Gary Gershony, co-founder and chief med- ical officer of AngioScore,
said: “The AngioSculpt represents an alternative to conventional balloon angioplasty catheters for the treatment of challeng- ing lesions because of its ability to achieve predicta- ble luminal expansion and a low rate of dissection. The results of the prospec- tive multicentre AGILITY trial demonstrated that use of the AngioSculpt was associated with a high rate of procedural success (91.4%); a low need for bailout stenting of the side-branch vessel (10.9%); and a very low rate of target lesion revas- cularisation (TLR) at nine months follow-up, with only one of the 93 patients (1.1%) experiencing TLR after 30 days. It is signifi- cant that the FDA has now allowed the company to present certain AGILITY trial results relating to bifurcations in its Instruc- tions for use.”
100th SynCardia Total Artificial Heart implanted in 2013
SynCardia Systems has announced that 100 SynCardia temporary
Market watch
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Total Artificial Hearts have been implanted by SynCardia certified cen- tres in 2013. A company release said that this milestone was achieved three months earlier than in 2012, when the 100 implant was performed on 16 October.
“2012 was a record- breaking year for Syn- Cardia with 125 implants of the Total Artificial Heart at 54 SynCar- dia certified centres,” said Michael Garippa, SynCardia CEO and president. “Reaching 100 implants three months earlier than we did last year is a testament to our long-term growth trajec- tory, which will be close to tripling since 2009. We expect this growth to continue as more hospitals adopt the Total Artificial Heart as the new standard of care for end-stage biventricular heart failure.”
The 100th implant
of the Total Artificial Heart was performed by Virginia Commonwealth University (VCU) Medi- cal Center in Richmond, USA.
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