Techniques

Integrity Life Sciences has somewhat belatedly announced FDA 510(k) clearance for its Integrity Spinal Care System. In a press release, issued this week, the company says it gained clearance on April 5th, 2011.

Initial findings from new study suggest successful delivery of PICSO® catheter and administration of PICSO® treatment designed to improve myocardial perfusion following primary PCI is sustained for the 90-minute study goal in first-three STEMI patients.

FDA has cleared ProPep’s Nerve Monitoring System, the first real-time nerve monitoring system specifically designed for use during robotic surgery.

Endometrial preparation does not seem to impact on success of EmbryoGlue, from Swedish fertility company Vitrolife, as study presented at ESHRE conference shows significant pregnancy rate improvement in all cases.

Synergetics USA, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT™, a novel vitrectomy system for the retinal surgery market.

Covidien’s V-Loc™ knotless suture has now been combined with its endoscopic suturing devices with claimed significant time saving for surgeons.

A few days ago we covered the story of Claret Medical’s first-in-human study using its original CE Pro embolic capture device. At the time we felt there were a few unanswered questions, so went back to Claret for some more information. This after all is a very promising looking device with genuine patient welfare consequences.

Kinetic Concepts, Inc. announced today that it has received FDA 510(k) clearance to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the management of closed surgical incisions.

CardioFocus, Inc.is drawing our attention to a study in the journal Heart Rhythm, demonstrating 98% acute success and durable pulmonary vein (PV) isolation rates achievable with a single, visually-guided HeartLight EAS ablation procedure.

Acellular dermal matrices provide good outcomes, with low complication rates, when used for breast reconstruction after mastectomy for breast cancer, according to a study in the June issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).

FDA’s executive summary of the state-of-play going into tomorrow’s circulatory devices panel meeting is exhaustive, thorough and actually pretty impressive. Yet again though it raises the question of when enough data is enough, because no doubt Edwards Lifesciences thinks its study already looks under every rock.

Mölnlycke Health Care has announced that it has acquired a pioneering electrical stimulation technology that is said to help accelerate wound healing. The product, currently marketed under the name of woundEL® has been purchased from Gerromed GmbH and is in an early phase of commercialisation.

AANA is probably the world’s best known annual forum for all things arthroscopy. It’s being held right now in Orlando and the program looks like the usual excellent selection of guest speakers and papers.

It’s only a month or so since tissue processing and medical device company Cryolife coughed up $22M to acquire Cardiogenesis Corporation. Now the Atlanta based company has announced that it is to acquire Hemosphere Inc., manufacturer of the HeRO® Graft.

Direct injection of stem cells and other biotherapeutics into the myocardium is quite a hot topic, so the announcement of an optimised injection catheter must be well timed.

Laparoscopic surgery instruments may need to be larger than the access portal through which they are delivered, which means some degree of internal assembly could open up possibilities for more useful devices. Now the way is clear as FDA issues its first such clearance.